SAFETY DATA SHEETS
Invivoscribe® ABI Assays

This document includes the Safety Data Sheets for reagents included in Invivoscribe ABI Assays, Catalog Numbers listed below.
Catalog Number

Description

11000031

IGH + IGK B-Cell Clonality Assay for ABI Fluorescence Detection

11000041

IGH + IGK B-Cell Clonality Assay MegaKit for ABI Fluorescence Detection

11010061

IGH Gene Clonality Assay for ABI Fluorescence Detection

11010081

IGH Gene Clonality Assay MegaKit for ABI Fluorescence Detection

11010051

IGH Gene Rearrangement Assay for ABI Fluorescence Detection

11010071

IGH Gene Rearrangement Assay MegaKit for ABI Fluorescence Detection

11020021

IGK Gene Clonality Assay for ABI Fluorescence Detection

11020031

IGK Gene Clonality Assay MegaKit for ABI Fluorescence Detection

11030011

IGL Gene Clonality Assay for ABI Fluorescence Detection

11030021

IGL Gene Clonality Assay MegaKit for ABI Fluorescence Detection

13110011

PML/RARα t(15;17) Translocation Assay for ABI Fluorescence Detection

12070101

T-cell Receptor Gamma Gene Rearrangement Assay 2.0 for ABI Fluorescence Detection

12070111

T-cell Receptor Gamma Gene Rearrangement Assay 2.0 MegaKit for ABI Fluorescence Detection

12070051

T-cell Receptor Gamma Gene Rearrangement Assay for ABI Fluorescence Detection

12050011

TCRB Gene Clonality Assay for ABI Fluorescence Detection

12050021

TCRB Gene Clonality Assay MegaKit for ABI Fluorescence Detection

12060011

TCRD Gene Clonality Assay for ABI Fluorescence Detection

12060021

TCRD Gene Clonality Assay MegaKit for ABI Fluorescence Detection

13100031

BCR/ABL t(9;22) Translocation Assay for ABI Fluorescence Detection

14120031

FLT3 Mutation Assay for ABI Fluorescence Detection

51010031

IGH Somatic Hypermutation Assay v2.0 for ABI Fluorescence Detection

51010041

IGH Somatic Hypermutation Assay MegaKit v2.0 for ABI Fluorescence Detection

SDS-Invivoscribe ABI Assays Rev. A | December 2022

Page 1 of 17

Invivoscribe® ABI Assays
Conforms to HCS 2021 – United States

SAFETY DATA SHEET
Section 1: Identification
GHS product identifier :IVS-0004 Clonal Control DNA
IVS-0007 Clonal Control DNA
IVS-0008 Clonal Control DNA
IVS-0009 Clonal Control DNA
IVS-0010 Clonal Control DNA
IVS-0013 Clonal Control DNA
IVS-0017 Clonal Control DNA
IVS-0019 Clonal Control DNA
IVS-0021 Clonal Control DNA
IVS-0024 Clonal Control DNA
IVS-0029 Clonal Control DNA
IVS-0030 Clonal Control DNA
IVS-0031 Clonal Control DNA
5% TCRG Positive Control DNA
IVS-0003 Clonal Control RNA
IVS-0011 Clonal Control RNA
IVS-0020 Clonal Control RNA
IVS-0032 Clonal Control RNA
IVS-0035 Clonal Control RNA
IVS-P001 Clonal Control DNA
IVS-P002 Clonal Control DNA
IVS-0000 Polyclonal Control DNA
Product typePart number :40880190
40880370
40880430
40880490
40880550
40880730
40880970
40881090
40881210
40881390
40881690
40881750
40881810
40883320
40890190
40890910
40891720
40892800
40893070
40900010
40900070
40920010:

Other means of identification :IVS-0004 Clonal Control DNA
IVS-0007 Clonal Control DNA
IVS-0008 Clonal Control DNA
IVS-0009 Clonal Control DNA
IVS-0010 Clonal Control DNA
IVS-0013 Clonal Control DNA
IVS-0017 Clonal Control DNA
IVS-0019 Clonal Control DNA
IVS-0021 Clonal Control DNA
IVS-0024 Clonal Control DNA
IVS-0029 Clonal Control DNA
IVS-0030 Clonal Control DNA
IVS-0031 Clonal Control DNA
5% TCRG Positive Control DNA
IVS-0003 Clonal Control RNA
IVS-0011 Clonal Control RNA
IVS-0020 Clonal Control RNA
IVS-0032 Clonal Control RNA
IVS-0035 Clonal Control RNA
IVS-P001 Clonal Control DNA
IVS-P002 Clonal Control DNA
IVS-0000 Polyclonal Control DNA

LiquidRelevant identified issues of the substance or mixture and uses advised against
Identified uses For use as qualitative PCR controls.
Restrictions on use:

For professional users only.

Supplier’s details:

Invivoscribe, Inc.
10222 Barnes Canyon Road, Building 1
San Diego, CA
92121 USA
Tel: 1 858 224 6000
Toll Free: 1 866 623 8105
Email: customerservice@invivoscribe.com
Website: invivoscribe.com

Emergency telephone (with hours of operation):

1 866 623 8105
8 AM – 5 PM PST

SDS-Invivoscribe ABI Assays Rev. A | December 2022

Page 2 of 17

Invivoscribe® ABI Assays

Section 2. Hazards Identification
OSHA/HCS status:

Classification of the substance or mixture:

While this material is not considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910:1200), this SDS contains valuable information critical to the safe
handling and proper use of the product. This SDS should be retained and available for
employees and other users of this product.
Not classified.

::No signal word.
No known significant effects or critical hazards.

:
:
:
:
:

Not applicable.
Not applicable.
Not applicable.
Not applicable.
None known.

GHS label elements
Signal word
Hazard statements
Precautionary statements
Prevention
Response
Storage
DisposalHazards not otherwise classified

Section 3. Compositions/information on ingredients
Substance/mixture: Mixture
Other means of identification: Not available.
There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified
as hazardous to health or the environment and hence require reporting in this section.
Occupational exposure limits, if available, are listed in Section 8.

Section 4. First aid measures
Description of necessary first aid measures
Eye contact : Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any
contact lenses. Get medical attention if irritation occurs.
Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical attention if symptoms
occur.
Skin contact : Flush contaminated skin with plenty of water. Get medical attention if symptoms occur.
Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small quantities
of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical attention if
symptoms occur.
Most important symptoms/effects, acute and delayed
Potential acute health effects
Eye contact: No known significant effects or critical hazards.
Inhalation: No known significant effects or critical hazards.
Skin contact: No known significant effects or critical hazards.
Ingestion: No known significant effects or critical hazards.
Over-exposure signs/symptoms
Eye contact: No known significant effects or critical hazards.
Inhalation: No known significant effects or critical hazards.
Skin contact: No known significant effects or critical hazards.
Ingestion: No known significant effects or critical hazards.
Indication of immediate medical attention and special treatment needed, if necessary
Notes to physician: Treat symptomatically. Contact poison treatment specialist immediately if large quantities have been
ingested or inhaled.
Specific treatments: No specific treatment.
Protection of first aiders: No action shall be taken involving any personal risk or without suitable training.
See toxicological information (Section 11)
SDS-Invivoscribe ABI Assays Rev. A | December 2022

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Invivoscribe® ABI Assays

Section 5. Fire-fighting measures
Extinguishing media
Suitable extinguishing media
Unsuitable extinguishing media
Specific hazards arising from the chemical
Hazardous thermal decomposition products
Special protective actions for fire-fighters

:
:
:
:
:

Special protective equipment for fire-fighters:

Use an extinguishing agent suitable for the surrounding fire.
None known.
In a fire or if heated, a pressure increase will occur and the container may burst.
No specific data.
Promptly isolate the scene by removing all persons from the vicinity of the incident if
there is a fire. No action shall be taken involving personal risk or without suitabletraining.
Fire-fighters should wear appropriate protective equipment and self-contained
breathing apparatus (SCBA) with a full face-piece operated in positive pressure
mode.

Section 6. Accidental release measures
Personal precautions, protective equipment and emergency procedures
For non-emergency personnel: No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from entering. Do nottouch or walk through spilled material. Put on appropriate personal protective equipment.
For emergency responders: If specialized clothing is required to deal with the spillage, take note of any information in Section 8
on suitable and unsuitable materials. See also the information in “For non-emergency personnel”.
Environmental precautions: Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains, and sewers.
Inform the relevant authorities if the product has caused environmental pollution (sewers,
waterways, soil or air).
Methods and materials for containment and cleaning up
Small spill: Stop leak if without risk. Move containers from spill area. Dilute with water and mop up if water soluble.
Alternatively, or if water soluble, absorb with an inert dry material and place in an appropriate waste disposal
container. Dispose of via a licensed waste disposal contractor.
Large spill: Stop leak if without risk. Move containers from spill area. Prevent entry into sewers, water courses, basements or
confined areas. Wash spillages into an effluent treatment plant or proceed as follows. Contain and collect spillage
with non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous earth and place in containerfor disposal according to local regulations (see Section 13). Dispose of via a licensed waste disposal contractor.
Note: see Section 1 for emergency contact information and Section 13 for waste disposal.

Section 7. Handling and storage
Precautions for safe handlingProtective measures
Advice on general occupational hygiene::

Put on appropriate personal protective equipment (see Section 8)..
Eating, drinking and smoking should be prohibited in areas where this material is handled,stored and processed. Workers should wash hands and face before eating, drinking andsmoking. See also Section 8 for additional information on hygiene measures.
Conditions for safe storage, including any incompatibilities : Store in accordance with local regulations. Store in original container
protected from direct sunlight in a dry, cool and well-ventilated area, awayfrom incompatible materials (see Section 10) and food and drink. Keep
container tightly closed and sealed until ready for use. Containers that havebeen opened must be carefully resealed and kept upright to prevent leakage.
Do not store in unlabeled containers. Use appropriate containment to avoid
environmental contamination. See Section 10 for incompatible materials
before handling or use.

Section 8. Exposure to controls/personal protection
Control parameters
Occupational exposure limits
None.
SDS-Invivoscribe ABI Assays Rev. A | December 2022

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Invivoscribe® ABI Assays

Section 8. Exposure to controls/personal protection
Appropriate engineering controls:

Good general ventilation should be sufficient to control worker exposure to airborne contaminants.

Environmental exposure controls:

Emissions from ventilation or work process equipment should be checked to ensure they comply
with the requirements of environmental protection legislation.

Individual protection measures
Hygiene measures: Wash hands, forearms and face thoroughly after handling chemical products, before eating, smoking andusing the lavatory and at the end of the working period. Appropriate techniques should be used to remove
potentially contaminated clothing. Wash contaminated clothing before reusing. Ensure that eyewash
stations and safety showers are close to the workstation location.
Eye/face protection: Safety eyewear complying with an approved standard should be used when a risk assessment indicated this isnecessary to avoid exposure to liquid splashes, mists, gases or dusts. In contact is possible, the following
protection should be worn, unless the assessment indicates a higher degree of protection: safety glasses withside-shields.
Skin protection
Hand protection:

Body protection:

Other skin protection:

Respiratory protection:

Chemical-resistant, impervious gloves complying with and approved standard should be worn at all times
when handling chemical products if a risk assessment indicates this is necessary.
Personal protective equipment for the body should be selected based on the task being performed and therisks involved and should be approved by a specialist before handling this product.
Appropriate footwear and any additional skin protection measures should be selected based on the task being
performed and the risks involved and should be approved by a specialist before handling this product.
Based on the hazard and potential for exposure, select a respirator that meets the appropriate standard or
certification. Respirators must be used according to a respiratory protection program to ensure proper fitting,training, and other important aspects of use.

Section 9. Physical and chemical properties
Appearance
Physical state
Color
Odor
Odor threshold
pH
Melting/freezing point
Initial boiling point and boiling range
Flash point
Evaporation rate
Flammability (solid, gas)
Lower and upper explosive (flammable) limits
Vapor pressure
Vapor density
Relative density
Solubility
Solubility in water
Partition coefficient: n-octanol/water
Auto-ignition temperature
Decomposition temperature
Viscosity
Flow time (ISO 2431)

SDS-Invivoscribe ABI Assays Rev. A | December 2022

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:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

Liquid. [Clear.]
Colorless.
Slight.
Not available.
Not available.
Not available.
Not available.
Does not flash.
Not available.
Not available.
Not available.
Not available.
Not available.
Not available.
Not available.
Not available.
Not applicable.
Not available.
Not available.
Not available.
Not available.

Page 5 of 17

Invivoscribe® ABI Assays

Section 10. Stability and reactivity
Reactivity :Chemical stability
Possibility of hazardous reactions
Conditions to avoid
Incompatible materials
Hazardous decomposition products

:
:
:
:
:

No dangerous reaction known under conditions of normal use.
The product is stable.
Under normal conditions of storage and use, hazardous reactions will not occur.
No specific data.
Reactive or incompatible with the following materials: oxidizing materials.
Under normal conditions of storage and use, hazardous decomposition products should not be
produced.

Section 11. Toxicological information
Information on toxicological effects
Acute toxicity
There is no data available.
Irritation/Corrosion
There is no data available.
Sensitization
There is no data available.
Mutagenicity
There is no data available.
Carcinogenicity
There is no data available.
Reproductive toxicity
There is no data available.
Teratogenicity
There is no data available.
Specific Target organ toxicity (single exposure)
There is no data available.
Specific Target organ toxicity (repeated exposure)
There is no data available.
Aspiration hazard
There is no data available.
Information on the likely routes of exposure : Routes on entry anticipated: Oral, Dermal, Inhalation.
Potential acute health effects
Eye contact
Inhalation
Skin contact
Ingestion::::

No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.

Symptoms related to the physical, chemical and toxicological characteristics
Eye contact: No known significant effects or critical hazards.
Inhalation: No known significant effects or critical hazards.
Skin contact: No known significant effects or critical hazards.
Ingestion: No known significant effects or critical hazards.
Delayed and immediate effects and also chronic effects from short and long term exposure
Short term exposure
Potential immediate effects: No known significant effects or critical hazards.
Potential delayed effects: No known significant effects or critical hazards.
Long term exposure
Potential immediate effects: No known significant effects or critical hazards.
Potential delayed effects: No known significant effects or critical hazards.

SDS-Invivoscribe ABI Assays Rev. A | December 2022

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Invivoscribe® ABI Assays

Section 11. Toxicological information
Potential chronic health effects
General:Carcinogenicity:
Mutagenicity:
Reproductive toxicity:
Numerical measures of toxicity
Acute toxicity estimates
There is no data available.

No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.
No known significant effects or critical hazards.

Section 12. Ecological information
Toxicity
There is no data available.
Persistence and degradability
There is no data available.
Bioaccumulative potential
There is no data available.
Mobility in soil
Soil/water partition coefficient (Koc)
Other adverse effects::

Not available.
No known significant effects or critical hazards.

Section 13. Disposal considerations
Disposal methods:

The generation of waste should be avoided or minimized wherever possible. Disposal of this product, solution andany by-products should comply with the requirements of environmental protection and waste disposal legislation
and any regional local authority requirements. Dispose of surplus and non-recyclable products via a licensed waste
disposal contractor. Waste should not be disposed of untreated to the sewer unless fully compliant with therequirements of all authorities with jurisdiction. Waste packaging should be recycled. Incineration or landfill should
only be considered when recycling is not feasible. This material and its container must be disposed of in a safe way.
Empty containers or liners may retain some product residues. Avoid dispersal of spilled material and runoff andcontact with soil, waterways, drains and sewers.

Section 14. Transport information
DOT Classification

IMDG

IATA

UN number

Not regulated.

Not regulated.

Not regulated.

UN proper shipping name

-

-

-

Transport hazard class(es)

-

-

-

Packing group

-

-

-

Environmental Hazards

No.

No.

No.
AERG : Not applicableSpecial precautions for user:

Transportation in bulk according to IMO instruments:

SDS-Invivoscribe ABI Assays Rev. A | December 2022

Transport within user’s premises: always transport in closed containersthat are upright and secure. Ensure that persons transporting the productknow what to do in the event of an accident or spillage.
Not available.

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Invivoscribe® ABI Assays

Section 15. Regulatory information
U.S. Federal regulations:

Clean Air Act Section 112 (b) Hazardous Air Pollutants (HAPs)
Clean Air Act Section 602 Class I Substances
Clean Air Act Section 602 Class II Substances
DEA List I Chemicals (Precursor Chemicals)
DEA List II Chemicals (Essential Chemicals)

:
:
:
:
:

TSCA 8(a) CDR Exempt/Partial exemption: Not determined.
Clean Water Act (CWA) 311: Edetic Acid; Hydochloric Acid.
ListedNot listed
Not listed
Not listed
Not listed

SARA 302/304
Composition/information on ingredients
Name

%

EHS

Hydrochloric acid

≤0.001Yes.

SARA 304 RQ

SARA 302 TPQ

SARA 304 RQ(lbs)(gallons)(lbs)(gallons)

500

-

5000

-

:

634763213.6 lbs / 288182499 kg:

Not applicable.
No products were found

:
:
:
:

None of the components are listed.
None of the components are listed.
None of the components are listed.
None of the components are listed.
This product does not require a Safe Harbor warning under California Prop. 65.

SARA 311/312
Classification
Composition/information on ingredients
State regulations
Massachussetts
New York
New Jersey
Pennsylvania
California Prop. 65

International regulations
Chemical Weapon Convention List Schedules I, II & III Chemicals
Not Listed.
Montreal Protocol
Not Listed.
Stockholm Convention on Persistent Organic Pollutants
Not Listed.
Rotterdam Convention on Prior Informed Consent (PIC)
Not Listed.
UNECE Aarhus Protocol on POPs and Heavy Metals
Not Listed.
Inventory list
United States (TSCA 8b):

All components are active or exempted.

Section 16. Other information
Procedure used to derive the classification
Classification
Not classified.
History
Date of issue/Date of revision
Date of previous issue
VersionInternal code
Prepared by

SDS-Invivoscribe ABI Assays Rev. A | December 2022

Justification

:
:
:
:
:

4/15/2021
Not applicable.
1651-004
Invivoscribe, Inc.

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Invivoscribe® ABI Assays

Section 16. Other information
Key to abbreviations:

ATE = Acute Toxicity Estimate
BCF = Bioconcentration Factor
GHS = Globally Harmonized System of Classification and Labelling of Chemicals
IATA = International Air Transport Association
IBC = Intermediate Bulk Container
IMGD = International Maritime Dangerous Goods
LogPow = logarithm of the octanol/water portion coefficient
MARPOL = International Convention for the Prevention of Pollution From Ships, 1973 as
modified by the Protocol of 1978 (“Marpol” = maritime pollution)
N/A = Not available
SGG = Segregation GroupUN = United Nations

Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above-named supplier, nor any of its subsidiaries, assumes any
liability whatsoever for the accuracy or completeness of the information contained herein.
Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution.
Although certain hazards are described herein, we cannot guarantee that these are the only hazards that exist.

SDS-Invivoscribe ABI Assays Rev. A | December 2022

Page 9 of 17

Conforms to HCS 2021 – United States

SAFETY DATA SHEET
Section 1: Identification
GHS product identifier
Amplification Control - 6FAM for ABI Fluorescence Detection

Part number

Specimen Control Size Ladder - 6FAM for ABI Fluorescence
Detection

20960021

Specimen Control Size Ladder - 6FAM for ABI Fluorescence
Detection

IGH Tube A - 6FAM for ABI Fluorescence Detection
IGH Tube C - HEX for ABI Fluorescence Detection
IGH Tube D - HEX for ABI Fluorescence Detection
IGH Tube E - 6FAM Fluorescence Detection
IGH Framework 1 (FR1) - 6FAM for ABI Fluorescence Detection
IGH Framework 3 (FR3) - HEX for ABI Fluorescence Detection
IGH Framework 2 (FR2) - 6FAM for ABI Fluorescence Detection
IGH Tube B - 6FAM for ABI Fluorescence Detection

21010011
21010031
21010041
21010051
21010061
21010081
21010091
21010101

IGH Tube A - 6FAM for ABI Fluorescence Detection
IGH Tube C - HEX for ABI Fluorescence Detection
IGH Tube D - HEX for ABI Fluorescence Detection
IGH Tube E - 6FAM Fluorescence Detection
IGH Framework 1 (FR1) - 6FAM for ABI Fluorescence Detection
IGH Framework 3 (FR3) - HEX for ABI Fluorescence Detection
IGH Framework 2 (FR2) - 6FAM for ABI Fluorescence Detection
IGH Tube B - 6FAM for ABI Fluorescence Detection

Hypermutation Mix 1 v2.0 - 6FAM for ABI Fluorescence Detection
Hypermutation Mix 2 v2.0 6FAM for ABI Fluorescence Detection

2101017121010181

Hypermutation Mix 1 v2.0 - 6FAM for ABI Fluorescence Detection
Hypermutation Mix 2 v2.0 6FAM for ABI Fluorescence Detection

IGK Tube A - 6FAM for ABI Fluorescence Detection
IGK Tube B - 6FAM for ABI Fluorescence Detection
IGL Tube - 6FAM for ABI Fluorescence Detection
TCRB Tube A - 6FAM & HEX for ABI Fluorescence Detection
TCRB Tube B - 6FAM for ABI Fluorescence Detection
TCRB Tube C - 6FAM & HEX for ABI Fluorescence Detection
TCRD Tube - 6FAM & HEX for ABI Fluorescence

21020011
21020021
21030011
22050011
22050021
22050031
22060011

IGK Tube A - 6FAM for ABI Fluorescence Detection
IGK Tube B - 6FAM for ABI Fluorescence Detection
IGL Tube - 6FAM for ABI Fluorescence Detection
TCRB Tube A - 6FAM & HEX for ABI Fluorescence Detection
TCRB Tube B - 6FAM for ABI Fluorescence Detection
TCRB Tube C - 6FAM & HEX for ABI Fluorescence Detection
TCRD Tube - 6FAM & HEX for ABI Fluorescence

T Cell Receptor Gamma Mix 2 - HEX for ABI Fluorescence Detection
T-Cell Receptor Gamma Mix 1 - 6FAM for ABI Fluorescence
Detection

22070021
22070071

T Cell Receptor Gamma Mix 2 - HEX for ABI Fluorescence Detection
T-Cell Receptor Gamma Mix 1 - 6FAM for ABI Fluorescence
Detection

TCRG - 6FAM
BCR/ABL t(9;22) Mix 1a for Gel Detection
BCR/ABL t(9;22) Mix 2a for Gel Detection
BCR/ABL t(9;22) Mix 3a for Gel Detection
BCR/ABL t(9;22) Mix 1b - HEX for ABI Fluorescence Detection
BCR/ABL t(9;22) Mix 2b - HEX for ABI Fluorescence Detection
BCR/ABL t(9;22) Mix 2c - HEX for ABI Fluorescence Detection
BCR/ABL t(9;22) Mix 3b - 6FAM for ABI Fluorescence Detection
BCR/ABL t(9;22) Mix 3c - 6FAM for ABI Fluorescence Detection
BCR/ABL t(9;22) Mix 3d - 6FAM for ABI Fluorescence Detection
PML/RARα t(15;17) Mix 1 - HEX for ABI Fluorescence Detection
PML/RARα t(15;17) Mix 2a for Gel Detection
PML/RARα t(15;17) Mix 2b - HEX for ABI Fluorescence Detection
PML/RARα t(15;17) Mix 2c - HEX for ABI Fluorescence Detection

22070091
23100010
23100020
23100030
23100041
23100051
23100061
23100071
23100081
23100101
23110011
23110020

TCRG - 6FAM
BCR/ABL t(9;22) Mix 1a for Gel Detection
BCR/ABL t(9;22) Mix 2a for Gel Detection
BCR/ABL t(9;22) Mix 3a for Gel Detection
BCR/ABL t(9;22) Mix 1b - HEX for ABI Fluorescence Detection
BCR/ABL t(9;22) Mix 2b - HEX for ABI Fluorescence Detection
BCR/ABL t(9;22) Mix 2c - HEX for ABI Fluorescence Detection
BCR/ABL t(9;22) Mix 3b - 6FAM for ABI Fluorescence Detection
BCR/ABL t(9;22) Mix 3c - 6FAM for ABI Fluorescence Detection
BCR/ABL t(9;22) Mix 3d - 6FAM for ABI Fluorescence Detection
PML/RARα t(15;17) Mix 1 - HEX for ABI Fluorescence Detection
PML/RARα t(15;17) Mix 2a for Gel Detection
PML/RARα t(15;17) Mix 2b - HEX for ABI Fluorescence Detection
PML/RARα t(15;17) Mix 2c - HEX for ABI Fluorescence Detection

20960011

FLT3 ITD Master Mix - 6FAM & HEX for ABI Fluorescence Detection

23110031
23110041
24120011

FLT3 D835 Master Mix - 6FAM for ABI Fluorescence Detection
Primer Hypermutation 100 μM - Unlabeled
IGH JH Primer 100 μM - Unlabeled24120031
30000000
31010380

Product type:

Other means of identification
Amplification Control - 6FAM for ABI Fluorescence Detection

FLT3 ITD Master Mix - 6FAM & HEX for ABI Fluorescence Detection

FLT3 D835 Master Mix - 6FAM for ABI Fluorescence Detection
Primer Hypermutation 100 μM - Unlabeled
IGH JH Primer 100 μM - Unlabeled

LiquidRelevant identified issues of the substance or mixture and uses advised against
Identified uses For amplification of gene rearrangements.
Restrictions on use: For professional users only.

SDS-Invivoscribe ABI Assays Rev. A | December 2022

Page 10 of 17

Invivoscribe® ABI Assays

Section 1: Identification
Supplier’s details:

Emergency telephone (with hours of operation):

Invivoscribe, Inc.
10222 Barnes Canyon Road, Building 1
San Diego, CA
92121 USA
Tel: 1 858 224 6000
Toll Free: 1 866 623 8105
Email: customerservice@invivoscribe.com
Website: invivoscribe.com
1 866 623 8105
8 AM – 5 PM PST

Section 2. Hazards Identification
OSHA/HCS status:

Classification of the substance or mixture
GHS label elements
Signal word
Hazard statements
Precautionary statements
Prevention
Response
Storage
DisposalHazards not otherwise classified:

While this material is not considered hazardous by the OSHA Hazard Communication
Standard (29 CFR 1910:1200), this SDS contains valuable information critical to the safe
handling and proper use of the product. This SDS should be retained and available for
employees and other users of this product.
Not classified.

::No signal word.
No known significant effects or critical hazards.

:
:
:
:
:

Not applicable.
Not applicable.
Not applicable.
Not applicable.
None known.

Section 3. Compositions/information on ingredients
Substance/mixture
Other means of identification
Ingredient Name
Dimethyl Sulfoxide::

MixtureNot available.
%≥1 - ≤3

CAS Number
67-68-5

Any concentration shown as a range is to protect confidentiality or is due to batch variation.
There are no additional ingredients present which, within the current knowledge of the supplier and in the concentrations applicable, are classified
as hazardous to health or the environment and hence require reporting in this section.
Occupational exposure limits, if available, are listed in Section 8.

Section 4. First aid measures
Description of necessary first aid measures
Eye contact : Immediately flush eyes with plenty of water, occasionally lifting the upper and lower eyelids. Check for and remove any
contact lenses. Get medical attention if irritation occurs.
Inhalation: Remove victim to fresh air and keep at rest in a position comfortable for breathing. Get medical attention if symptoms
occur.
Skin contact : Flush contaminated skin with plenty of water. Get medical attention if symptoms occur.
Ingestion: Wash out mouth with water. If material has been swallowed and the exposed person is conscious, give small
quantities of water to drink. Do not induce vomiting unless directed to do so by medical personnel. Get medical
attention if symptoms occur.
Most important symptoms/effects, acute and delayed

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Section 4. First aid measures
Potential acute health effects
Eye contact:
No known significant effects or critical hazards.
Inhalation:
No known significant effects or critical hazards.
Skin contact:
No known significant effects or critical hazards.
Ingestion:
No known significant effects or critical hazards.
Over-exposure signs/symptoms
Eye contact:
No known significant effects or critical hazards.
Inhalation:
No known significant effects or critical hazards.
Skin contact:
No known significant effects or critical hazards.
Ingestion:
No known significant effects or critical hazards.
Indication of immediate medical attention and special treatment needed, if necessary
Notes to physician:
Treat symptomatically. Contact poison treatment specialist immediately if large quantities have been
ingested or inhaled.
Specific treatments:
No specific treatment.
Protection of first aiders:
No action shall be taken involving any personal risk or without suitable training.
See toxicological information (Section 11)

Section 5. Fire-fighting measures
Extinguishing media
Suitable extinguishing media
Unsuitable extinguishing media
Specific hazards arising from the chemical
Hazardous thermal decomposition products

Special protective actions for fire-fighters:

Special protective equipment for fire-fighters ::::Use an extinguishing agent suitable for the surrounding fire.
None known.
In a fire or if heated, a pressure increase will occur and the container may burst.
: Decomposition products may include the following materials:
carbon dioxidecarbon monoxide
sulfur oxides
Promptly isolate the scene by removing all persons from the vicinity of the incident if there isa fire. No action shall be taken involving personal risk or without suitable training.
Fire-fighters should wear appropriate protective equipment and self-contained breathingapparatus (SCBA) with a full face-piece operated in positive pressure mode.

Section 6. Accidental release measures
Personal precautions, protective equipment and emergency procedures
For non-emergency personnel : No action shall be taken involving any personal risk or without suitable training.
Evacuate surrounding areas. Keep unnecessary and unprotected personnel from entering. Do nottouch or walk through spilled material. Put on appropriate personal protective equipment.
For emergency responders: If specialized clothing is required to deal with the spillage, take note of any information in Section 8 onsuitable and unsuitable materials. See also the information in “For non-emergency personnel”.
Environmental precautions: Avoid dispersal of spilled material and runoff and contact with soil, waterways, drains, and sewers.
Inform the relevant authorities if the product has caused environmental pollution (sewers, waterways,
soil or air).
Methods and materials for containment and cleaning up
Small spill : Stop leak if without risk. Move containers from spill area. Dilute with water and mop up if water soluble.
Alternatively, or if water soluble, absorb with an inert dry material and place in an appropriate waste disposal
container. Dispose of via a licensed waste disposal contractor.
Large spill : Stop leak if without risk. Move containers from spill area. Prevent entry into sewers, water courses,
basements or confined areas. Wash spillages into an effluent treatment plant or proceed as follows. Containand collect spillage with non-combustible, absorbent material e.g. sand, earth, vermiculite or diatomaceous
earth and place in container for disposal according to local regulations (see Section 13). Dispose of via alicensed waste disposal contractor. Note: see Section 1 for emergency contact information and Section 13 forwaste disposal.

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Section 7. Handling and storage
Precautions for safe handlingProtective measures
Advice on general occupational hygiene: Put on appropriate personal protective equipment (see Section 8).
: Eating, drinking and smoking should be prohibited in areas where this material is handled,stored and processed. Workers should wash hands and face before eating, drinking andsmoking. See also Section 8 for additional information on hygiene measures.

Conditions for safe storage, including any incompatibilities:

Store in accordance with local regulations. Store in original container
protected from direct sunlight in a dry, cool and well-ventilated area,
away from incompatible materials (see Section 10) and food anddrink. Keep container tightly closed and sealed until ready for use.
Containers that have been opened must be carefully resealed andkept upright to prevent leakage. Do not store in unlabeledcontainers. Use appropriate containment to avoid environmental
contamination. See Section 10 for incompatible materials before
handling or use.

Section 8. Exposure to controls/personal protection
Control parameters
Occupational exposure limits
Ingredient Name
Dimethyl sulfoxide
Appropriate engineering controls:

Environmental exposure controls:

Exposure limits
AIHA WEEL (United States, 7/2018).
TWA: 250 ppm 8 hours
Good general ventilation should be sufficient to control worker exposure to airborne
contaminants.
Emissions from ventilation or work process equipment should be checked to ensure they comply
with the requirements of environmental protection legislation.

Individual protection measures
Hygiene measures: Wash hands, forearms and face thoroughly after handling chemical products, before eating, smoking and using
the lavatory and at the end of the working period. Appropriate techniques should be used to remove
potentially contaminated clothing. Wash contaminated clothing before reusing. Ensure that eyewash stations
and safety showers are close to the workstation location..
Eye/face protection : Safety eyewear complying with an approved standard should be used when a risk assessment indicated this isnecessary to avoid exposure to liquid splashes, mists, gases or dusts. In contact is possible, the following
protection should be worn, unless the assessment indicates a higher degree of protection: safety glasses withside-shields.
Skin protection
Hand protection: Chemical-resistant, impervious gloves complying with and approved standard should be worn at all times
when handling chemical products if a risk assessment indicates this is necessary.
Body protection: Personal protective equipment for the body should be selected based on the task being performed and therisks involved and should be approved by a specialist before handling this product.
Other skin protection : Appropriate footwear and any additional skin protection measures should be selected based on the task being
performed and the risks involved and should be approved by a specialist before handling this product.
Respiratory protection: Based on the hazard and potential for exposure, select a respirator that meets the appropriate standard or
certification. Respirators must be used according to a respiratory protection program to ensure proper fitting,training, and other important aspects of use.

Section 9. Physical and chemical properties
Appearance
Physical state
Color
Odor
Odor thresholdpH
SDS-Invivoscribe ABI Assays Rev. A | December 2022

:
:
:
:
:

Liquid. [Clear.]
Colorless, light yellow, light pink, light blue or light orange.
Odorless.
Not available.
7 to 9.5.
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Section 9. Physical and chemical properties
Melting/freezing point
Initial boiling point and boiling range
Flash point
Evaporation rate
Flammability (solid, gas)
Lower and upper explosive (flammable) limits
Vapor pressure
Vapor density
Relative density
Solubility
Solubility in water
Partition coefficient: n-octanol/water
Auto-ignition temperature
Decomposition temperature
Viscosity
Flow time (ISO 2431)

:
:
:
:
:
:
:
:
:
:
:
:
:
:
:
:

Not available.
Not available.
Does not flash.
Not available.
Not available.
Not available.
Not available.
Not available.
Not available.
Not available.
Not available.
Not applicable.
Not available.
Not available.
Not available.
Not available.

Section 10. Stability and reactivity
Reactivity
Chemical stability
Possibility of hazardous reactions
Conditions to avoid
Incompatible materials Hazardous
decomposition products

:
:
:
:
:
:

No specific test data related to reactivity for this product or its ingredients.
The product is stable.
Under normal conditions of storage and use, hazardous reactions will not occur.
No specific data.
Reactive or incompatible with the following materials: oxidizing materials.
Under normal conditions of storage and use, hazardous decomposition products should not be
produced.

Section 11. Toxicological information
Information on toxicological effects
Acute toxicity
Product/ingredient name
Dimethyl sulfoxide

Result
LD50 Dermal
LD50 Oral

Species
Rat
Rat

Dose
40000 mg/kg
14500 mg/kg

Exposure-

Irritation/Corrosion
There is no data available.
Sensitization
There is no data available.
Mutagenicity
There is no data available.
Carcinogenicity
There is no data available.
Reproductive toxicity
There is no data available.
Teratogenicity
There is no data available.
Specific Target organ toxicity (single exposure)
There is no data available.
Specific Target organ toxicity (repeated exposure)
There is no data available.
Aspiration hazard
There is no data available.

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Section 11. Toxicological information
Information on the likely routes of exposure: Routes on entry anticipated: Oral, Dermal, Inhalation.
Potential acute health effects
Eye contact: No known significant effects or critical hazards.
Inhalation: No known significant effects or critical hazards.
Skin contact: No known significant effects or critical hazards.
Ingestion: No known significant effects or critical hazards.
Symptoms related to the physical, chemical and toxicological characteristics
Eye contact: No known significant effects or critical hazards.
Inhalation: No known significant effects or critical hazards.
Skin contact: No known significant effects or critical hazards.
Ingestion: No known significant effects or critical hazards.
Delayed and immediate effects and also chronic effects from short- and long-term exposure
Short term exposure
Potential immediate effects: No known significant effects or critical hazards.
Potential delayed effects: No known significant effects or critical hazards.
Long term exposure
Potential immediate effects: No known significant effects or critical hazards.
Potential delayed effects: No known significant effects or critical hazards.
Potential chronic health effects
General: No known significant effects or critical hazards.
Carcinogenicity: No known significant effects or critical hazards.
Mutagenicity: No known significant effects or critical hazards.
Reproductive toxicity: No known significant effects or critical hazards.
Numerical measures of toxicity
Acute toxicity estimates
Inhalation
Inhalation
Oral
DermalInhalation (dusts andProduct/ingredient name(gases)(vapors)(mg/kg)(mg/kg)mists) (mg/l)(ppm)(mg/l)
Dimethyl sulfoxide
14500
40000
N/A
N/A
N/A

Section 12. Ecological information
Toxicity
Product/ingredient name
Dimethyl sulfoxide

ResultAcute EC50 18299 μg/L Marine water
Acute LC50 37.437 mg/L Marine water
Acute LC50 25000 ppm Fresh waterSpecies
Algae – Nitzschia pungens
Crustaceans – Artemia sp.
Daphnie – Daphnia magna – Neonate

Exposure
96 hour
48 hours
48 hours

Acute LC50 34000000 μg/L Fresh water
Chronic NOEC 3323 μg/L Marine water
Chronic NOEC 100 μl/L Fresh water

Fish – Pimephales promelas
Algea – Nitzschia pungens
Daphnia – Daphnia magna – Juvenile(Fledgling, Hatchling, Weanling)

96 hours
96 hours
21 days

Persistence and degradability
There is no data available.
Bioaccumulative potential
Product/ingredient name
Dimethyl sulfoxide
Mobility in soil
Soil/water partition coefficient (Koc)
Other adverse effects

SDS-Invivoscribe ABI Assays Rev. A | December 2022

LogP
-1.35
:
:

BCF
3.16

Potentiallow

Not available.
No known significant effects or critical hazards.

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Invivoscribe® ABI Assays

Section 13. Disposal considerations
Disposal methods:

The generation of waste should be avoided or minimized wherever possible. Disposal of this product, solution and any
by-products should comply with the requirements of environmental protection and waste disposal legislation and any
regional local authority requirements. Dispose of surplus and non-recyclable products via a licensed waste disposal
contractor. Waste should not be disposed of untreated to the sewer unless fully compliant with the requirements of
all authorities with jurisdiction. Waste packaging should be recycled. Incineration or landfill should only be consideredwhen recycling is not feasible. This material and its container must be disposed of in a safe way. Empty containers or
liners may retain some product residues. Avoid dispersal of spilled material and runoff and contact with soil,
waterways, drains and sewers.

Section 14. Transport information
DOT Classification
Not regulated.
No.

IMDG
Not regulated.
No.

IATA
UN number
Not regulated.
UN proper shipping name
Transport hazard class(es)Packing group
Environmental Hazards
No.
AERG : Not applicableSpecial precautions for user
: Transport within user’s premises: always transport in closed containers that are upright and secure.
Ensure that persons transporting the product know what to do in the event of an accident or spillage.
Transportation in bulk according to IMO instruments: Not available.

Section 15. Regulatory information
U.S. Federal regulations:

Clean Air Act Section 112 (b) Hazardous Air Pollutants (HAPs)
Clean Air Act Section 602 Class I Substances
Clean Air Act Section 602 Class II Substances
DEA List I Chemicals (Precursor Chemicals)
DEA List II Chemicals (Essential Chemicals)

:
:
:
:
:

TSCA 8(a) CDR Exempt/Partial exemption: Not determined.
Clean Water Act (CWA) 311: Hydrochloric Acid.
ListedNot listed
Not listed
Not listed
Not listed

SARA 302/304
Composition/information on ingredientsName
Hydrochloric acid
SARA 304 RQ

%
:

EHS

SARA 302 TPQ(lbs)(gallons)

Yes.
500≤0.0025277831623,1 lbs / 126135556,9 kg-

SARA 304 RQ(lbs)(gallons)

5000-

SARA 311/312
Classification: Not applicable.
Composition/information on ingredients
No products were foundState regulations
Massachusetts: None of the components are listed.
New York: None of the components are listed.
New Jersey: The components are listed: Dimethyl sulfoxide.
Pennsylvania: None of the components are listed.
California Prop. 65
This product does not require a Safe Harbor warning under California Prop. 65.
International regulations
Chemical Weapon Convention List Schedules I, II & III Chemicals
Not Listed.
Montreal Protocol
Not Listed.

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Section 15. Regulatory information
Stockholm Convention on Persistent Organic Pollutants
Not Listed.
Rotterdam Convention on Prior Informed Consent (PIC)
Not Listed.
UNECE Aarhus Protocol on POPs and Heavy Metals
Not Listed.
Inventory list
United States (TSCA 8b): All components are active or exempted.

Section 16. Other information
Procedure used to derive the classification
Classification
Not classified.
History
Date of issue/Date of revision:
Date of previous issue:
Version:Internal code:
Prepared by:
Key to abbreviations:

Justification

4/15/2021
Not applicable.
1651-005
Invivoscribe, Inc..
ATE = Acute Toxicity Estimate
BCF = Bioconcentration Factor
GHS = Globally Harmonized System of Classification and Labelling of Chemicals
IATA = International Air Transport Association
IBC = Intermediate Bulk Container
IMGD = International Maritime Dangerous Goods
LogPow = logarithm of the octanol/water portion coefficient
MARPOL = International Convention for the Prevention of Pollution From Ships, 1973 as modified
by the Protocol of 1978 (“Marpol” = maritime pollution)
N/A = Not available
SGG = Segregation GroupUN = United Nations

Notice to reader
To the best of our knowledge, the information contained herein is accurate. However, neither the above-named supplier, nor any of its subsidiaries, assumes any liability whatsoever forthe accuracy or completeness of the information contained herein.
Final determination of suitability of any material is the sole responsibility of the user. All materials may present unknown hazards and should be used with caution. Although certain
hazards are described herein, we cannot guarantee that these are the only hazards that exist.

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