69192 Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 

support disaster survivors during 

response missions. ACF is requesting 

immediate approval for this information 

collection but also requesting comments 

to inform any updates prior to 

requesting an extension of approval 

within six months. 

DATES: Comments due within 60 days of 

publication. In compliance with the 

requirements of the Paperwork 

Reduction Act (PRA) of 1995, ACF is 

soliciting public comment on the 

specific aspects of the information 

collection described in this notice. 

These comments will be considered 

prior to requesting an extension of 

approval. 

ADDRESSES: Copies of the proposed 

collection of information can be 

obtained and comments may be 

submitted by emailing infocollection@

acf.hhs.gov. Identify all by the title of 

the information collection. 

SUPPLEMENTARY INFORMATION: 

Description: OHSEPR’s case managers 

would use this collection during an 

intake assessment to identify a disaster 

survivor’s unmet needs and to work 

with the survivor to develop a case 

management plan based on the 

survivor’s responses. ACF is requesting 

that OMB grant a 180-day approval for 

this request under procedures for 

expedited processing, as authorized 

under 44 U.S.C. 3507 (subsection j). The 

information collected is essential to the 

mission of the agency and an 

unanticipated event occurred that could 

reasonably result in public harm if 

normal PRA clearance procedures are 

followed. ACF is requesting expedited 

processing to ensure that the agency is 

operationally ready to support disaster 

survivors in Hawai’i who were impacted 

by the wildfires that began August 8, 

2023, on Maui County. A request for 

review under normal procedures will be 

submitted within 180 days of the 

approval for this request. 

Respondents: Disaster Survivors. 

ANNUAL BURDEN ESTIMATES

Data collection 

Annual 

number of 

respondents 

Total 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Annual 

burden hours 

Disaster Human Services Case Management Intake Assessment—Survivor 9,000 1 1.5 13,500 

Case Management Plan—Case Manager ....................................................... 180 50 1 9,000 

Resource Referral Form—Case Manager ....................................................... 180 50 1 9,000 

Case Record Notes—Case Manager .............................................................. 180 50 1 9,000 

Survivor Satisfaction Survey—Survivor ........................................................... 9,000 1 .25 2,250 

Estimated Total Annual Burden Hours ..................................................... ........................ ........................ ........................ 42,750 

Comments: The Department 

specifically requests comments on (a) 

whether the proposed collection of 

information is necessary for the proper 

performance of the functions of the 

agency, including whether the 

information shall have practical utility; 

(b) the accuracy of the agency’s estimate 

of the burden of the proposed collection 

of information; (c) the quality, utility, 

and clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. Consideration will be given 

to comments and suggestions submitted 

within 60 days of this publication. 

Comments will be considered and any 

necessary updates to materials made 

prior to, and responses provided in, the 

submission to OMB that will follow this 

public comment period. 

Authority: The Disaster Human 

Services Case Management Program is 

authorized through appropriations 

language under the Children and 

Families Services account. It is operated 

by the ACF Office of Human Services 

Emergency Preparedness and Response, 

which is the lead in HHS for human 

service preparation for, response to, and 

recovery from, natural disasters. 

Mary B. Jones, 

ACF/OPRE Certifying Officer. 

[FR Doc. 2023–22294 Filed 10–4–23; 8:45 am] 

BILLING CODE 4184–PC–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4182] 

Revocation of Eleven Authorizations of 

Emergency Use of In Vitro Diagnostic 

Device for Detection and/or Diagnosis 

of COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorizations (EUAs) (the 

Authorizations) issued to Luminostics, 

Inc., for the Clip COVID Rapid Antigen 

Test; NeuMoDx Molecular, Inc., a 

QIAGEN Company, for the NeuMoDx 

Flu A–B/RSV/SARS–CoV–2 Vantage 

Assay; LGC, Biosearch Technologies for 

the SARS–CoV–2 Real-Time and EndPoint RT–PCR Test; LGC, Biosearch 

Technologies, for the Biosearch 

Technologies SARS–CoV–2 ultra-highthroughput End-Point RT–PCR Test; 

Becton, Dickinson and Co. for the BD 

Veritor At-Home COVID–19 Test; Verily 

Life Sciences for the Verily COVID–19 

RT–PCR Test; Clinical Research 

Sequencing Platform (CRSP), LLC at the 

Broad Institute of MIT and Harvard for 

the CRSP SARS–CoV–2 Real-time 

Reverse Transcriptase (RT)–PCR 

Diagnostic Assay (Version 3); Xtrava 

Health for the SPERA COVID–19 Ag 

Test; Exact Sciences Laboratories for the 

COVID–Flu Multiplex Assay; Exact 

Sciences Laboratories for the SARS– 

CoV–2 (N gene detection) Test; and dba 

SpectronRx for the Hymon SARS–CoV– 

2 Test Kit. FDA revoked these 

Authorizations under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) as 

requested by the Authorization holders. 

The revocations, which include an 

explanation of the reasons for each 

revocation, are reprinted in this 

document. 

DATES: The Authorization for the 

Luminostics, Inc.’s, Clip COVID Rapid 

Antigen Test is revoked as of May 5, 

2023. The Authorization for the 

NeuMoDx Molecular, Inc., a QIAGEN 

Company, for the NeuMoDx Flu A–B/ 

RSV/SARS–CoV–2 Vantage Assay is 

revoked as of May 24, 2023. The 

Authorization for the LGC, Biosearch 

Technologies for the SARS–CoV–2 RealVerDate Sep<11>2014 18:37 Oct 04, 2023 Jkt 262001 PO 00000 Frm 00078 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1

ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 69193 

Time and End-Point RT–PCR Test is 

revoked as of June 1, 2023. The 

Authorization for the LGC, Biosearch 

Technologies, for the Biosearch 

Technologies SARS–CoV–2 ultra-highthroughput End-Point RT–PCR Test is 

revoked as of June 1, 2023. The 

Authorization for the Becton, Dickinson 

and Co.’s BD Veritor At-Home COVID– 

19 Test is revoked as of June 15, 2023. 

The Authorization for the Verily Life 

Sciences’ Verily COVID–19 RT–PCR 

Test is revoked as of June 21, 2023. The 

Authorization for the Clinical Research 

Sequencing Platform (CRSP), LLC at the 

Broad Institute of MIT and Harvard for 

the CRSP SARS–CoV–2 Real-time 

Reverse Transcriptase (RT)-PCR 

Diagnostic Assay (Version 3) is revoked 

as of July 3, 2023. The Authorization for 

the Xtrava Health’s SPERA COVID–19 

Ag Test is revoked as of August 3, 2023. 

The Authorization for the Exact 

Sciences Laboratories’ COVID–Flu 

Multiplex Assay is revoked as of August 

18, 2023. The Authorization for the 

Exact Sciences Laboratories’ SARS– 

CoV–2 (N gene detection) Test is 

revoked as of August 18, 2023. The 

Authorization for the dba SpectronRx’s 

Hymon SARS–CoV–2 Test Kit is 

revoked as of August 23, 2023. 

ADDRESSES: Submit a written request for 

a single copy of the revocations to the 

Office of Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5431, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request or 

include a Fax number to which the 

revocations may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocations. 

FOR FURTHER INFORMATION CONTACT: Kim 

Sapsford-Medintz, Office of Product 

Evaluation and Quality, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 3216, 

Silver Spring, MD 20993–0002, 301– 

796–0311 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) allows FDA 

to strengthen the public health 

protections against biological, chemical, 

radiological, or nuclear agent or agents. 

Among other things, section 564 of the 

FD&C Act allows FDA to authorize the 

use of an unapproved medical product 

or an unapproved use of an approved 

medical product in certain situations. 

On December 7, 2020, FDA issued the 

Authorization to Luminostics, Inc., for 

the for the Clip COVID Rapid Antigen 

Test, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on April 23, 2021 (86 

FR 21749), as required by section 

564(h)(1) of the FD&C Act. On March 

25, 2021, FDA issued the Authorization 

to NeuMoDx Molecular, Inc., a QIAGEN 

Company, for the NeuMoDx Flu A–B/ 

RSV/SARS–CoV–2 Vantage Assay, 

subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on July 23, 2021 (86 FR 

39040), as required by section 564(h)(1) 

of the FD&C Act. On April 15, 2021, 

FDA issued the Authorization to LGC, 

Biosearch Technologies for the SARS– 

CoV–2 Real-Time and End-Point RT– 

PCR Test. Notice of the issuance of this 

Authorization was published in the 

Federal Register on July 23, 2021 (86 FR 

39040), subject to the terms of the 

Authorization. On August 24, 2021, 

FDA issued the Authorization to Becton, 

Dickinson and Co. for the BD Veritor AtHome COVID–19 Test, subject to the 

terms of the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

October 28, 2021 (86 FR 59740), as 

required by section 564(h)(1) of the 

FD&C Act. On April 26, 2022, FDA 

issued the Authorization to LGC, 

Biosearch Technologies, for the 

Biosearch Technologies SARS–CoV–2 

ultra-high-throughput End-Point RT– 

PCR Test, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on July 22, 2022 (87 FR 

43877), as required by section 564(h)(1) 

of the FD&C Act. On September 8, 2020, 

FDA issued the Authorization to Verily 

Life Sciences for the Verily COVID–19 

RT–PCR Test, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on November 20, 2020 

(85 FR 74346), as required by section 

564(h)(1) of the FD&C Act. On March 5, 

2021, FDA issued the Authorization to 

Clinical Research Sequencing Platform 

(CRSP), LLC at the Broad Institute of 

MIT and Harvard for the CRSP SARS– 

CoV–2 Real-time Reverse Transcriptase 

(RT)-PCR Diagnostic Assay (Version 3), 

subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on July 23, 2021 (86 FR 

39040), as required by section 564(h)(1) 

of the FD&C Act. On October 12, 2021, 

FDA issued the Authorization to Xtrava 

Health for the SPERA COVID–19 Ag 

Test, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on March 22, 2022 (87 

FR 16198), as required by section 

564(h)(1) of the FD&C Act. On July 1, 

2021, FDA issued the Authorization to 

Exact Sciences Laboratories for the 

COVID–Flu Multiplex Assay, subject to 

the terms of the Authorization. Notice of 

the issuance of this Authorization was 

published in the Federal Register on 

October 28, 2021 (86 FR 59740), as 

required by section 564(h)(1) of the 

FD&C Act. On March 31, 2020, FDA 

issued the Authorization to Exact 

Sciences Laboratories for the SARS– 

CoV–2 (N gene detection) Test, subject 

to the terms of the Authorization. Notice 

of the issuance of this Authorization 

was published in the Federal Register 

on November 20, 2020 (85 FR 74346), as 

required by section 564(h)(1) of the 

FD&C Act. On May 22, 2020, FDA 

issued the Authorization to dba 

SpectronRx for the Hymon SARS–CoV– 

2 Test Kit, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on November 20, 2020 

(85 FR 74346), as required by section 

564(h)(1) of the FD&C Act. 

Subsequent updates to the 

Authorizations were made available on 

FDA’s website. The authorization of a 

device for emergency use under section 

564 of the FD&C Act may, pursuant to 

section 564(g)(2) of the FD&C Act, be 

revoked when the criteria under section 

564(c) of the FD&C Act for issuance of 

such authorization are no longer met 

(section 564(g)(2)(B) of the FD&C Act), 

or other circumstances make such 

revocation appropriate to protect the 

public health or safety (section 

564(g)(2)(C) of the FD&C Act). 

II. Authorization Revocation Requests 

In a request received by FDA on May 

2, 2023, Luminostics, Inc. requested the 

withdrawal of, and on May 5, 2023, 

FDA revoked, the Authorization for the 

Luminostics, Inc.’s Clip COVID Rapid 

Antigen Test. Because Luminostics, Inc. 

notified FDA that there are no viable 

Clip COVID Rapid Antigen Test reagents 

remaining in distribution in the United 

States and requested FDA withdraw the 

Luminostics, Inc.’s Clip COVID Rapid 

Antigen Test, FDA has determined that 

it is appropriate to protect the public 

health or safety to revoke this 

Authorization. 

In a request received by FDA on May 

11, 2023, NeuMoDx Molecular, Inc., a 

QIAGEN Company requested revocation 


ddrumheller on DSK120RN23PROD with NOTICES1
69194 Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 

of, and on May 24, 2023, FDA revoked, 

the Authorization for the NeuMoDx 

Molecular, Inc., a QIAGEN Company’s, 

NeuMoDx Flu A–B/RSV/SARS–CoV–2 

Vantage Assay. Because NeuMoDx 

Molecular, Inc., a QIAGEN Company, 

notified FDA that it has decided to 

discontinue distribution of the 

NeuMoDx Flu A–B/RSV/SARS–CoV–2 

Vantage Assay in the United States and 

requested FDA voluntary revocation of 

the EUA for the NeuMoDx Flu A–B/ 

RSV/SARS–CoV–2 Vantage Assay, FDA 

has determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. 

In a request received by FDA on May 

1, 2023, LGC, Biosearch Technologies 

requested revocation of, and on June 1, 

2023, FDA revoked, the Authorization 

for the LGC Biosearch Technologies’ 

SARS–CoV–2 Real-Time and End-Point 

RT–PCR Test. Because LGC, Biosearch 

Technologies notified FDA that it is no 

longer marketing the SARS–CoV–2 RealTime and End-Point RT–PCR Test and 

requested FDA revoke the EUA for the 

LGC Biosearch Technologies SARS– 

CoV–2 Real-Time and End-Point RT– 

PCR Test, FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

In a request received by FDA on May 

1, 2023, LGC, Biosearch Technologies 

requested revocation of, and on June 1, 

2023, FDA revoked, the Authorization 

for the LGC Biosearch Technologies’ 

SARS–CoV–2 ultra-high-throughput 

End-Point RT–PCR Test. Because LGC, 

Biosearch Technologies notified FDA 

that it is no longer marketing the SARS– 

CoV–2 ultra-high-throughput End-Point 

RT–PCR Test and requested FDA revoke 

the EUA for the LGC Biosearch 

Technologies SARS–CoV–2 ultra-highthroughput End-Point RT–PCR Test, 

FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

In a request received by FDA on May 

30, 2023, Becton, Dickinson and Co. 

requested withdrawal of, and on June 

15, 2023, FDA revoked, the 

Authorization for the Becton, Dickinson 

and Co.’s BD Veritor At-Home COVID– 

19 Test. Because Becton, Dickinson and 

Co. notified FDA that it has 

discontinued the sale of BD Veritor AtHome COVID–19 Test and requested 

FDA withdraw the EUA for the Becton, 

Dickinson and Co.’s BD Veritor AtHome COVID–19 Test, FDA has 

determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. 

In a request received by FDA on June 

13, 2023, Verily Life Sciences requested 

withdrawal of, and on June 21, 2023, 

FDA revoked, the Authorization for the 

Verily Life Sciences’ Verily COVID–19 

RT–PCR Test. Because Verily Life 

Sciences notified FDA that it is no 

longer distributing the Verily COVID–19 

Nasal Swab Kits (authorized as part of 

the Verily COVID–19 RT–PCR Test) or 

offering testing services at the Verily 

Life Sciences’ laboratory using the 

Verily COVID–19 RT–PCR Test and 

requested FDA withdraw the EUA for 

the Verily Life Sciences’ Verily COVID– 

19 RT–PCR Test, FDA has determined 

that it is appropriate to protect the 

public health or safety to revoke this 

Authorization. 

In a request received by FDA on June 

14, 2023, Clinical Research Sequencing 

Platform (CRSP), LLC at the Broad 

Institute of MIT and Harvard, requested 

voluntary revocation of, and on July 3, 

2023, FDA revoked, the Authorization 

for the CRSP, LLC at the Broad Institute 

of MIT and Harvard’s CRSP SARS–CoV– 

2 Real-time Reverse Transcriptase (RT)– 

PCR Diagnostic Assay (Version 3). 

Because CRSP, LLC at the Broad 

Institute of MIT and Harvard notified 

FDA that it is no longer distributing the 

CRSP Self-swab Kits (authorized as part 

of the CRSP SARS–CoV–2 Real-time 

RT–PCR Diagnostic Assay (Version 3)) 

or offering testing services at the CRSP, 

LLC at the Broad Institute of MIT and 

Harvard laboratory using the CRSP 

SARS–CoV–2 Real-time RT–PCR 

Diagnostic Assay (Version 3), and 

requested FDA revoke the EUA for the 

CRSP, LLC at the Broad Institute of MIT 

and Harvard’s CRSP SARS–CoV–2 Realtime RT–PCR Diagnostic Assay (Version 

3), FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

In a request received by FDA on July 

18, 2023, Xtrava Health requested the 

withdrawal of, and on August 3, 2023, 

FDA revoked, the Authorization for the 

Xtrava Health’s SPERA COVID–19 Ag 

Test. Because Xtrava Health notified 

FDA that there are no SPERA COVID– 

19 Ag Test reagents in distribution in 

the United States and requested FDA 

withdraw the Xtrava Health’s, SPERA 

COVID–19 Ag Test, FDA has 

determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. 

In a request received by FDA on 

August 1, 2023, Exact Sciences 

Laboratories requested the withdrawal 

of, and on August 18, 2023, FDA 

revoked, the Authorization for the Exact 

Sciences Laboratories’ COVID-Flu 

Multiplex Assay. Because Exact 

Sciences Laboratories notified FDA that 

they have discontinued use of the 

COVID-Flu Multiplex Assay at Exact 

Sciences Laboratories and requested 

FDA withdraw the Exact Sciences 

Laboratories’ COVID-Flu Multiplex 

Assay, FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

In a request received by FDA on 

August 1, 2023, Exact Sciences 

Laboratories requested the withdrawal 

of, and on August 18, 2023, FDA 

revoked, the Authorization for the Exact 

Sciences Laboratories’ SARS–CoV–2 (N 

gene detection) Test. Because Exact 

Sciences Laboratories notified FDA that 

they have discontinued use of the 

SARS–CoV–2 (N gene detection) Test at 

Exact Sciences Laboratories and 

requested FDA withdraw the Exact 

Sciences Laboratories’ SARS–CoV–2 (N 

gene detection) Test, FDA has 

determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. 

In a request received by FDA on 

March 24, 2023, dba SpectronRx 

requested the withdrawal of, and on 

August 23, 2023, FDA revoked, the 

Authorization for the dba SpectronRx’s 

Hymon SARS–CoV–2 Test Kit. Because 

dba SpectronRx notified FDA that they 

are discontinuing the distribution of the 

Hymon SARS–CoV–2 Test Kit and 

requested FDA withdraw the dba 

SpectronRx for the Hymon SARS–CoV– 

2 Test Kit, FDA has determined that it 

is appropriate to protect the public 

health or safety to revoke this 

Authorization. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocations are available on the internet 

at https://www.regulations.gov/. 

IV. The Revocations 

Having concluded that the criteria for 

revocation of the Authorizations under 

section 564(g)(2)(C) of the FD&C Act are 

met, FDA has revoked the EUA of 

Luminostics, Inc.’s, Clip COVID Rapid 

Antigen Test, NeuMoDx Molecular, Inc., 

a QIAGEN Company’s, NeuMoDx Flu 

A–B/RSV/SARS–CoV–2 Vantage Assay, 

LGC Biosearch Technologies’ SARS– 

CoV–2 Real-Time and End-Point RT– 

PCR Test, LGC Biosearch Technologies’ 

SARS–CoV–2 ultra-high-throughput 

End-Point RT–PCR Test, Becton, 

Dickinson and Co.’s BD Veritor AtHome COVID–19 Test, Verily Life 

Sciences’ Verily COVID–19 RT–PCR 

Test, Clinical Research Sequencing 

Platform (CRSP), LLC at the Broad 

Institute of MIT and Harvard’s CRSP 

SARS–CoV–2 Real-time Reverse 

Transcriptase (RT)–PCR Diagnostic 

Assay (Version 3), Xtrava Health’s 

SPERA COVID–19 Ag Test, Exact 

Sciences Laboratories’ COVID-Flu 

Multiplex Assay, Exact Sciences 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 69195 

Laboratories’ SARS–CoV–2 (N gene 

detection) Test, and dba SpectronRx’s 

Hymon SARS–CoV–2 Test Kit. These 

revocations in their entirety follow and 

provide an explanation of the reasons 

for each revocation, as required by 

section 564(h)(1) of the FD&C Act. 

BILLING CODE 4164–01–P 


ddrumheller on DSK120RN23PROD with NOTICES1EN05OC23.066</GPH>

BalaR:aja Ph.Di 

President and CEO 

Luminosti¢s, lt1c. 

483898'.emontSlvd, Suittlll:2, 

Fretnont; C~ 9453'8 

Re: R.evocation ot'EUA:2U290'7 

C>ellt Dr. Raja: 

This letter fa in response to tlte request. ftoinLtitninosti(..'li, me., in aletterreceived Mar 2, 2023, 

that the U. $; Food and Drug Administration (FDA)WithdraW the EU A for the Clip COVID 

lllq>id Antigen test issued on December 7,. 2020, reissued March 4, 20~2. and revised on 

September 23, 2021, and November 1, 2022:. FDA understands that as oftlte date of this letter 

tltere .are no viable Clip COVIDRapid Antigen Test reagents remaining in distributionin the 

United States. 

The allthorizajionof a <ievke for emergeu,cy use under sec#on 564 of the Fei.teral Food, Drug; 

and Cosmetfo Act (the Act)(21 U.S.C, 360bbb~3) may,pursua.ntto section 564(g)(2) of the A~ 

be revoked when citcwnstartces maki: such revocation appropriate t<> protect the pub Ii¢ health <>r 

saf~y (~cti◊rt 564(g)(2)(C) of the A~). :aecause Ll,lttlln<>Stics; Inc; h!i$ requested FDA withdraw 

the EUAfor the Clip Covto R.aptd Antigen Test, FDA bas determined tliai iHs appropriate to 

protect the public health ·or safety to revokethis authorization:. .. Accordingly,.FDA hereby revokes 

EUA.202907 for the Clip covm Rapid Antigen Test, pim.uanno section 564(3X2)(C)of tlte 

A(..1:, As ofthe date <>fthi& letter, the Clip COVIORapid Antigen. Test isJ10 l<>ngerffllthorized :for 

emergen1;1y llSe by FDA. • •• • 

Notice of this revocatiQn will he published 1n theFWeraiRegiste1t pursuant to section 564(h)(l) 

oftheAct. 

Sincerely. 

Jeffrey E. Shuret\ M.D., J.D. 

Directctt 

Center for Devices and Radiological Health 

Fo.od and Drug Administratio11 
69196 Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 


ddrumheller on DSK120RN23PROD with NOTICES1EN05OC23.067</GPH>

1"'" .. -••·~•1,, 

{. U.S. FOOD & DRUG 

ADMINISTRATION 

May 24, 2023 

Eveline Arnold, Ph.D. 

Director, Regulatory Affairs 

Clinical, Medical, and Regulatory Affairs (CMRA) 

NeuMoDx Molecular, Inc., a QIAGEN Company 

1250 Eisenhower Place 

Ann Arbor, MI 48108 

Re: Revocation ofEUA202947 

Dear Dr. Arnold: 

TI1is letter is in response to QIAGEN's request on behalf ofNeuMoDx Molecular, Inc., a 

QIAGEN Company, in an email received May 11, 2023, that the U.S. Food and Drug 

Administration (FDA) revoke the EUAforthe Neu1foDx Flu A-B/RSV/SARS-CoV-2 Vantage 

Assay issued on March 25, 2021, and revised on September 23, 2021. QIAGEN has decided to 

discontinue distribution of the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay in the 

United States and requested volut1tary revocation of the EUA. 

TI1e authorization of a device for emergency use under section 564 of the Federal Food, Drug, 

and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, 

be revoked ,;vhen circumstances make such revocation appropriate to protect the public health or 

safety (section 564(g)(2)(C) of the Act). Because QIAGEN, on behalf of NeuMoDx Molecular, 

Inc., has requested FDA revoke the EUA for the NeuMoDx Flt1 A-B/RSV/SARS-CoV-2 

Vantage Assay, FDA has detem1ined that it is appropriate to protect the public health or safety to 

revoke this authorization. Accordingly, FDA hereby revokes EU A202947 for the NeuMoDx Flu 

A-B/RSV/SARS-CoV-2 Vantage Assay, pursuant to section 564(g)(2)(C) of the Act. As ofthe 

date of this letter, the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay is no longer 

authorized for emergency use by FDA. 

Notice of this revocation will be published in the Federal Register, pursuant to section 564(11)(1) 

of the Act. 

Sincerely, 

//s// 

Jeffrey E. Shuren, M.D., J.D. 

Director 

Center for Devices and Radiological Health 

food and Drug Administration 
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 69197 


ddrumheller on DSK120RN23PROD with NOTICES1EN05OC23.068</GPH>

U.S. FOOD & DRUG AOMINIST!IAT!ON 

Ray Bandziulis, Ph.D. 

Director of Regulatory Affairs 

LGC, Biosearch Technologies 

2905 Parameter Street 

Middleton, WI 53562 

Re: Revocation ofEUA203030 

Dear Dr. Bandziulis: 

June 1, 2023 

TI1is letter is in response to the request from LGC, Biosearch Technologies, in an email received 

May l, 2023, that the U.S. Food and Drug Administration (FDA) revoke the EUA for the 

Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test issued on April 

15, 2021, and revised on September 23, 2021 and May 3, 2022. LGC, Biosearch Technologies 

indicated that they are no longer marketing the authorized product and requested that the EDA be 

revoked. FDA understands that, as of the date of this letter, there are no viable Biosearch 

Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test reagents remaining in 

distribution in the United States. 

The authorization ofa device for emergency use under section 564 of the Federal Food, Dmg, 

and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(gX2) ofthe Act, 

be revoked when circumstances make such revocation appropriate to protect the public health or 

safety (section 564(gX2)(C) ofthe Act). Because LGC, Biosearch Technologies has requested 

that FDA revoke the EUA for Biosearch Technologies SARS-CoV-2 Real-Time and End-Point 

RT-PCR Test, FDA has detennined that it is appropriate, to protect the public health or safety, to 

revoke this authorization. Accordingly, FDA hereby revokes EUA203030 for the Biosearch 

Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR Test, pursuant to section 

564(g)(2)(C) ofthe Act. As of the date of this letter, the Biosearch Technologies SARS-CoV-2 

Real-Time and End-Point RT-PCR Test is no longer authorized for emergency use by FDA. 

Notice of this revocation will be published in the Federal Register, pursuant to section 564(hXl) 

of the Act. 

Sincerely, 

ifs!/ 

Jeflrey E. Shuren, M.D., J.D. 

Director 

Center for Devices and Radiological Health 

Food and Drug Administration 
69198 Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 


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u~s. FOOD:& DRUG 

AOMIN!URAJJON 

Ray Baridziulis,.Ph.D. 

Ditectot of Regulatory Affairs 

LOC,.BiosearchTe¢lmologij;)!; 

2905 Parameter Street 

Midcileton, WI 53562 

Re: Re-vocation ofEUA.210561 

Dear Dt. Bandziulfa: 

This letter is in response to the request from LGC, Biosearch Technologies, in an email received 

May l; 2023, thattheUS. Food and Drug Administration (FDA) revoke the EUA for the 

Biosearch Technologies SARS-CoV-2 ultfii>-high-throughput End~Point RT,PCR Test issued on 

April 26, 2022. LGC; Biosearch Tecl:mologies indicated that they are no longer nlarketing the 

authorized product and requ~edthatthe EUA be revoked, FDA understands that as of the date 

of this.letter customers will discontinue use of the Biosearch·Technologies SARS-Co V-2ultra• 

hlgh~throughput End-Point RT;;PCR Test reagents. 

1:he authorization of a: device for emergency use under section 564.ofthe Federal FoO<l, Drug, 

and Cosmetic Act (the Act)(21 us;c. 360bbb~3) may, pursuantto section 564(g)(2) of the Act, 

be revoked when circumstances mak.e such revocation appropriate to protect the public health ot 

s:a:fety (section564(gX2)(C) of the Act). Because LGC, Biosearch Technologies has requested 

FDA revoke the EUA for Biosearch Technologies SARS-CoV .:.2 ultra.:.high-throughput EndPoint RT~.PCR Test, FDA has determined that it is appropriate to protect the public health or 

safety to revoke this authorization. Accorciingly, FDA hereby revokes EUA210561 for the 

Biosearch Technologies SAR.S~Co V-2 ultra-high-throughput End.Point RT--PCR T~ pursuant 

to section 564(g)(2)(C)of theAct. As of the date of this letter, the Biosea:rch Technologi1:1s 

SARS-CoV-2 ultra-high-throughput End-PointRT~PCR Test is no longer authorized for 

emergency use by FDA 

Notice of this revocation will be published in the Federal Register; pursuant to. sectron 564(h)( 1) 

oftheAct. 

Sincerely. 

!Isl! 

Jefiley E. Sharen. M.D.,. J.D. 

Director 

Center for Devices and Radiological Health 

Food at),d Drug Administration 
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 69199 


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■ U.S. FOOD & DRUG 

Al)MJIIISTUTION 

Amanda Ker, 

Regulatory Speciallst 

Becton. Dickinson and Co. 

7 Loveton Circle 

Sparks, MD 21152 

Re: Revocationof]):UA210417 

Dear Amanda Ker: 

Jm1e 15, 2023 

'U1is letter is in response to the request.from Becton, Dickinson and Co («BD"), in an email 

received May 30, 2023, tha:t the U.S. Food and Drug Administration (FDA) withdraw the EU A 

for the BD Veritor At-Home COVID· 19 Test issued on AugU$t 24, 2021, reissued on November 

22, 2021 and revised on August 4, 2022, November 1, 2022 and February 21, 2023 .. BD 

indicated that they discontinued the sale. the authorized product and requested that the EUA be 

withdrawn. FDA understands that as of the date ofthis letter there are no viable.BD Veritor AtHome COVID-19 Test reagents re1naining in distribution in the United States. 

'The authorization of a device for emergency use under section 564 of the Federal .Food, Drug, 

and Cosmetic Act (the Act) (21 U.S.C. 360bbb·3) may, pursuant fo section 564(g)(2) of the Act, 

be revoked when circumstances make si.1ch revocation appropriate to protect the public health or 

safety (section 564(g)(2)(C) of the Act). Becau$e Bb has requested. FDA withdraw the EUA for 

the BD Veritor At-Home COVID-1.9 Test, FDA has d.etermined that it is appropriate t(Yprotect 

the public health or safety to revoke this authorization. Accordingly, FDAhereby revokes 

EUA210417 for the BD Veritor At-Home COVlD• 19 Test, pursuant to section. 564(g)(2)(C) of 

the Act. As of the date of this Jetter, the BD Veritor At-Home COVID-19 Test is no longer 

authorized for emergency use by FDA. 

Notice ofthi$ revocation will be published in the FederalRegister, pursuant to section 564(h)(l) 

oftheAct. 

Sincerely, 

Jeffrey E. Sbti.ten, ttD,, J.D. 

Director 

Center for Devices and .Radiological Health 

Food and Drug Administration 
69200 Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 


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U.S. FOOD & DRUG 

ADMIMl$TU,TIOl4 

Aarthi Srinivasan 

Regulatory Affairs 

Verily Life Sciences 

269 E Grand Ave. 

South Sa,n Francisco, CA 94080 

Re: Revocation ofEUA.202054 

Dear Aarthi Srinivasan: 

June 21, 2023 

This letter is in response to the request from Verily Life Sciences, it1 an email received June 13, 

2023, that the U.S. Food and Drug Admil1istration (FDA)withdraw the EUA for the Verily 

COVID-19 RT-PCR Test issued on September 8, 2020,reissued ml December 18, 2020, March 

30, 2021, and November 8, 2021, and revised on September 23,.2021 and November 15, 2022. 

Verily Life Sciences indicated that they are no longer distributing the Verily COVID-19 Nasal 

Swab Kits (authorized as part of the Verily COVID-19 RT-PCR Test) or offering testil1g services 

at the Vet'ily Life Scierices laboratory usitlgthe Verily COVID-19 RT-PCR Test andteqttested 

that the EUA be withdrawn. 

The authorization of a device for e111erge11cy use under section 564 of the Federal Food, Drug, 

and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursua11tto section 564(g)(2) of the Act, 

be revoked when circitmstances make such revocation appropriate to protect the public health or 

safety (section 564(g)(2)(C) of the Act). Because Verily Life Sciences has requested FDA 

withdraw the EUAforthe Verily COVID-19 RT-PCR Test, FDA has detemiined that it is 

appropriate to ptotect the public· health or safety to revoke this authorization. Accordingly, FDA 

hereby revokes EUA202054 fotthe Verily COVID-19 RT-PCR Test, pursuant to section 

564(g)(2)(C) of the Act. As of the date of this letter, the Verily COVID-19 RT-PCR Test is no 

longer authorized for emergency use by FDA. 

Notice of this i-evocation will be published in the Federal Register, pursuant to section 564(hX1) 

ofthe Act. 

Sirtcerely, 

Jeffrey E. Shuren, M.D., J.D. 

Director 

Center for Devices at:td Radiological Health 

Food and Drug Admmistration 
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 69201 


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U.S. FOOD & DRUG 

Ab MINISTRATION 

July 3, 2023 

Charles Kolifrath 

Associate Director, Regulatory Affairs, Oe11omics Platform 

Clinical Research Sequencing Platfonn (CRSP), LLC at the Broad Institute of MIT and Harvard 

320 Charles Street 

Cambridge, MA 02141 

Re: Revocation ofEUA210089 

Dear Charles Kolifrath: 

This letter is in response to the requestfrom Clinical Research Sequencing Platform (CRSP), 

LLC at the Broad Institute of MIT and Harvard, in an email received June 14, 2023, that the U.S. 

Food and Drug Administration (FDA) revoke the EUA for the CRSP SARS-Co V-2 Real-time 

Reverse. Transcriptase (RT}-PCR Diagnostic Assay (Version 3) issued on March 5, 2021, 

reissued on May 13, 2021, and June 3, 2022, and revised on September 23, 2021. In addition, on 

June 15, 2021, FDA included the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-

PCR Diagnostic Assay (Version 3) under Exhibit l of the April 20, 2021, pooling and serial 

testing amendment. Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute 

of MIT and Harvard indicated that as of the date of this letter they are no longer distributing the 

CRSP Self-swab Kits (authorized as part of the CRSP SARS-CoV-2 Real-time Reverse 

Transcriptase (RT)-PCR Diagnostic Assay (Version 3)) or offering testing services al the 

Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard 

laboratory using the CRSP SARS-Co V-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic 

Assay (Version 3) and.requested voluntary revocation ofthe EUA. 

The authorization of a device for emergency use under section 564 of the Federal Food, Drug, 

and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, 

be revoked when circumstances make such revocation appropriate to protect the public health or 

safety (section 564(g)(2)(C) of the Act), Because Clinical Research Sequencing Platform 

(CRSP), LLC at the Broad Institute of.MIT and Harvard has requested voluntary revocation of 

the EUA for the CRSP SARS-Co V-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic 

Assay (Version 3), FDA has determined that it is appropriate to protect the public health or 

safety to revoke this authorization. Accordingly, .FDA hereby revokes EUA210089 for the CRSP 

SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3), 

pursuant to section 564(g)(2)(C) of the Act. As of the date of this letter, the CRSP SARS-CoV•2 

Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) is no longer 

authorized for emergency use by FDA. 

Page 2 ...., Charles Kolitrath,. Clini()S} .Ilesearch SeqttencingPlatfonn (CRSP). LLC attrn? Broad 

~itμte of MIT an~ Harvard 

Notice ofthis revocation win be published in the FederatRegister; pursuant to.section 564(h)(l) 

ofthe Act. 

Sincerely, 

!ls/I 

JeffreyE. Slmren, M.D,; J.D. 

Director 

Center for Devices and Radiological Health 

Food and Dtug Administration 
69202 Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 


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August 3, 2023 

Iman Sadr.eddin 

Co-Founder, COO 

Xtrava Health 

3080 Olcott Street, Suite C20l 

Santa Clara, CA 95054 

Re: Revotation of.EUA210544 

Dear Mr. tman Sadreddin: 

This letter is in response to the request from Xtrava Health, in an email received July 18, 2023, 

that the U.S. Food and Drug Administration (FDA) withdraw the BUA for the SPERA COVID• 

19 Ag Test issued on October 12, 2021, revised on November I, 2022, and reissued May 22, 

2023. FDA understands that as of the date of this letter there are no SPERA COVID-19 Ag Test 

reagents in distribution in the United States, 

The authorization of a device for emergency use under section 564 of the Federal Food, Drug, 

and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, 

be revoked. when circumstances make such revocation appropriate to protect the public health or 

safety (si':lction 564(g)(2)(C) of the Act) .. Because Xtrava Health has requested that FDA 

withdraw the EU A for the SPERA COVID-19 Ag Test, FDA has determined that it is 

appropriate to protect the public health or safety to revoke this authorization. Accordingly, FDA 

hereby revokes BUA2.I0:544 for the SPERA COVID-19 Ag Test, pursuant to section 

564(g)(2)(C) of the Act. As ofthe date of this letter, the SPERA COVlD-19 Ag Test is.no longer 

authorized for emergency use by FDA. 

Notice of this revocation will be p'ublished in the Federal RegLster, pursuant to section 564(h)(l) 

oftheAct. 

Sincerely, 

!Isl/ 

Jeffrey E. Shuren, M.D., J.D. 

Director 

Center for Devices and Radiological Health 

Food and Drug Administration 
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 69203 


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■ U.S. FOOD & DRUG 

AOMINISTIIATION 

lb;iago Braga 

Sr, Regulatory Affairs Specialist 

Exact Sciences Laboratories 

650 Forward Drive 

Madison, WI 53711 

Re: Revocation ofEUA203022 

.Dear Tiiiago Braga; 

August 18, 2023 

This letter is in response to the request from Exact Sciences Laboratories, in a letter received via 

email AtJgust 1, 2023, that the U.S. Food aitd Drug Administration (FDA) withdraw the EUA for 

the COVID-Flu Multiplex Assay issued on July 1, 2021, and revised on Septe:mber 23, 2021, 

February 14, 2022, and August 2, 2022. Exact Sciences Laboratories indicated thatthey have 

discontinued use of the COVID-Flu Multiplex Assay at Exact Sciences Laboratories) located at 

650 Forward Drive, Madison, WI 53711, and requested tbat the EUA be withdrawn, 

The authorizati()n of a device for emergency use uitder section 564 of the Federal Food, Drug, 

and Cosmetic Act (the Act) (21 U:S.C. 360bbb-3) may,.pursμant to section 564(g)(2) of the Act, 

be revoked when circumstances make such revocation appropriate to protect the public health or 

safety (section 564(g)(2)(C) of the Act). Because Exact Sciences Laborat()ries has requested 

FDA withdraw the EUA for the COVID~Flu Multiplex Assay, FDA has determined that it.is 

appropriate to protect the public health or safety to {'.evoke this authorization. Accordingly, FDA 

hereby revokes EUA203022 for the COVIl)~Flu Mul!.iplex Assay,.pursuant to section 

564(g)(2)(C) oftbe Act. As of the date of this letter, the COVIO•,Flil Multiplex Assay is 1:io 

longer authod.zed fot emerge11cy use byFDA 

Notice of this revocation will be published in the Federal Register, pursuantto section 564(11)(1) 

of the Act. 

Sincerely, 

Ellen J. Flanner:y; J.D. 

Deputy Center Director for Policy 

Director, Office of Policy 

Ce11tei: for Devices and Radiological Health 

Food andDrugAdministration 
69204 Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 


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U.S. FOOD & DR.UG 

AOMHmmv,m::iN 

'Thiago Braga 

Sr. Regulatory A:ftairs Specialist 

Exact Sciences Laboratories 

650 Forward Drive 

Madison, WI 53711 

Re: Revocation ofEUA200367 

Dear Thiago Braga: 

Ailgust 18, 2023 

111is .letter is in response to the request from Exact S.ciences uiboratories, in a letter received via 

email August 1, .. 2023, that the U.S. Food and Drug Administration (FDA) withdraw the EUA for 

the SARS-Co V-2 (N gene detection) Test that was originally authorized under the March 31, 

2020, Emergency Use Authorization (EUA) for Molecular-based Laboratory Developed Tests 

for Detection of Nucleic Acid from SARS-CoV-2 (High Complexity LDT Umb.rella EUA) on 

May 22, 2020, and then issued an individual EUA on August 3, 2020, that was revised on 

August 28, 2020, and September 23, 2021. Exact Sciences Laboratories indicated that they have 

discontinued use of the SARS-Co V-2 (N gene detection) Test at Exact Sciences Laboratories, 

located at 650 .Foi:ward Drive, Madison, WI 53711 and 145 E. Badger Road Ste. 100, Madison, 

WI 53713, and requested that the EUA be withdrawn. 

The authorization ofa device for emergency use under section 564 of the FederaLFood, Drug, 

and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, 

be revoked whe11circumstances make such revoc.ation appropriate to protect the public health or 

safety (section 564(g)(2)© ofthe Act). Because Exact Sciences .Laboratories has requested FDA 

withdr.aw the EUA for the SARS•CoV-2 (N gene detection) Test, FDA has detennined that it is 

appropriate to protect the public health. or safety to revoke this authorization. Accordingly, FDA 

hereby revokes rmA200367 for th.e SARS-Co V-2 (N gene detection) Test, pursuant to section. 

564(g)(2)(C) ofthe Act. As of the date of this letter, the SARS-CoV-2 (N gene detection) Test is 

110 longer authorized foremergency use by FDA. 

Notice of this revocatio.n will be published in the Federal. Register, pursuant to section 564(h)(l) 

of the Act. • 

Sincerely, 

Ifs/! 

Elle11 J. Flannery, J.D. 

Deputy Center Director for Policy 

Director, Office of Policy 

Center for Devices and Radiological Health 

Food aa1d Drug Administration 
Federal Register / Vol. 88, No. 192 / Thursday, October 5, 2023 / Notices 69205 

Dated: October 2, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22188 Filed 10–4–23; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–1848] 

Stimulant Use Disorders: Developing 

Drugs for Treatment; Draft Guidance 

for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of a draft 

guidance for industry entitled 

‘‘Stimulant Use Disorders: Developing 

Drugs for Treatment.’’ The purpose of 

this draft guidance is to assist sponsors 

in the clinical development of drugs for 

the treatment of stimulant use disorders. 

Specifically, this guidance addresses 

FDA’s current recommendations 

regarding the overall development 

program and clinical trial designs for 

the development of drugs to support 

indications of treatment of moderate to 


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U.S. FOOD & DRUG llt'IMINISTRAT!ON 

August 23, 2023 

Beth Kraemer, RPh 

Director of Quality, Regulato1y & Technical Compliance 

dba SpectronR,x 

9550 Zionsville Rd Suite 1 

Indianapolis, IN 46268 

Re: Revocation ofEUA200415 

Dear Beth Kraemer: 

This letter is in response to the request from dha SpectronRx, received via email on March 24, 

2023, that the U.S. Food and Drng Administration (FDA) revoke the EUA for the Hymon SARSCo V-2 Test Kit issued on May 22, 2020, and amended on August 11, 2020. dba SpectronRx 

indicated that they are discontinuing the distribution of the Hymon S ARS-Co V-2 Test Kit and 

requested that the EUA be revoked. FDA understands that as of the date of this letter there will 

no longer be any viable Hymon SARS-Co V-2 Test Kit reagents remaining in distribution in the 

United States. 

The authorization of a device for emergency use under section 564 of the Federal Food, Drug, 

and Cosmetic Act (the Act) (21 U.S.C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, 

be revoked when circumstances make such revocation appropriate to protect the public health or 

safety (section 564(gX2XC) of the Act). Because dba SpcctronRx has requested that FDA 

tenninate the EUA for the Hymon SARS-CoV-2 Test Kit, FDA has determined that it is 

appropriate to protect the public health or safety to revoke this authorization. Accordingly, FDA 

hereby revokes EUA200415 for the Hymon SARS-CoV-2 Test Kit, pursuant to section 

564(gX2)(C) of the Act. As of the date of this Jetter, the Hymon SARS-CoV-2 Test Kit is no 

longer authorized for emergency use by FDA. 

Notice of this revocation will be published in the Federal Register, pursuant to section 564(h)(l) 

ofthe Act. 

Sincerely, 

llslf 

Jeffrey E. Shuren, M.D., J.D. 

Director 

Center for Devices and Radiological Health 

Food and Drug Administration