SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text

Standard Reference

CE marking Conformité
Européene Notified Body
Reference no. ###The requirements for accreditationand market surveillance relating to
the marketing of products

MDD 93/42/EEC
IVDD 98/79/EC Article 16.2

Manufacturer

Indicates the medical device
manufacturer

ISO 15223-1:2016
Reference no. 5.1.1

Authorized
representative in theEuropean Community

Indicates the authorized
representative in the EuropeanCommunity

ISO 15223-1:2016
Reference no. 5.1.2

Date of manufactureIndicates the date when the medicaldevice was manufactured

ISO 15223-1:2016
Reference no. 5.1.3
ISO 7000:2014
Reference no. 2497

Use byIndicates the date after which themedical device is not to be used

ISO 15223-1:2016
Reference no. 5.1.4
ISO 7000:2014
Reference no. 2607

Batch code

Indicates the manufacturer's batch
code to identify the batch or lot

ISO 15223-1:2016
Reference no. 5.1.5
ISO 7000:2014
Reference no. 2492

Catalog number

Indicates the manufacturer's
catalogue number to identify themedical device

ISO 15223-1:2016
Reference no. 5.1.6
ISO 7000:2014
Reference no. 2493

Serial numberSterile

Indicates the manufacturer's serial
number so that a specific medical
device can be identified

Indicates a medical device that has
been subjected to a sterilization
process

ISO 15223-1:2016
Reference no. 5.1.7
ISO 7000:2014
Reference no. 2498
ISO 15223-1:2016
Reference no. 5.2.1
EU IVDD 98/79/EC, ANNEX
I.B.(2.3)
EU IVDR 2017/746 20.2(I)ISO 7000:2014
Reference no. 2499

SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text

Standard Reference

Sterilized using ethyleneoxide

Indicates a medical device that has
been sterilized using ethylene oxide.

ISO 15223-1:2016
Reference no. 5.2.3
ISO 7000:2014
Reference no. 2501

Sterilized usingirradiation

Indicates a medical device that has
been sterilized using irradiation

ISO 15223-1:2016
Reference no. 5.2.4
ISO 7000:2014
Reference no. 2501

Fragile, handle with care

Indicates a medical device that canbe broken or damaged if nothandled carefully

ISO 15223-1:2016
Reference no. 5.3.1
ISO 7000:2014
Reference no. 0621

Keep away from sunlight

Indicates a medical device thatneeds protection from light sources

ISO 15223-1:2016
Reference no. 5.3.2
ISO 7000:2014
Reference no. 0624

Keep dry

Indicates a medical device thatneeds protection from moisture

ISO 15223-1:2016
Reference no. 5.3.4
ISO 7000:2014
Reference no. 0626

Lower limit oftemperature

Indicates the lower limit oftemperature to which the medical
device can be safely exposed

ISO 15223-1:2016
Reference no. 5.3.5
ISO 7000:2014
Reference no. 0534

Upper limit oftemperature

Indicates the upper limit oftemperature to which the medical
device can be safely exposed

ISO 15223-1:2016
Reference no. 5.3.6
ISO 7000:2014
Reference no. 0533

Temperature limit

Indicates the temperature limits towhich the medical device can besafely exposed

ISO 15223-1:2016
Reference no. 5.3.7
ISO 7000:2014
Reference no. 0632

Humidity limitation

Indicates the range of humidity towhich the medical device can besafely exposed

ISO 15223-1:2016
Reference no. 5.3.8
ISO 7000:2014
Reference no. 2620

SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text

Standard Reference

Recycable

Indicates that an item can berecycled

ISO 7000
Reference no. 1135

Biological risks

Indicates that there are potential
biological risks associated with themedical device

ISO 15223-1:2016
Reference no. 5.4.1
ISO 7000:2014
Reference no. 0659

Do not reuse

Indicates a medical device that isintended for one use, or for use on asingle patient during a single
procedureISO 15223-1:2016
Reference no. 5.4.2
ISO 7000:2014
Reference no. 1051

Consult instructions foruse

Indicates the need for the user toconsult the instructions for use

ISO 15223-1:2016
Reference no. 5.4.3
ISO 7000:2014
Reference no.1641

CautionIndicates the need for the user toconsult the instructions for use forimportant cautionary informationISO 15223-1:2016
Reference no. 5.4.4
ISO 7000:2014
Reference no. 0434

In vitro diagnostic
medical device

Indicates a medical device that isintended to be used as an in vitro
diagnostic medical device

ISO 15223-1:2016
Reference no. 5.5.1

Control

Indicates a control material that isintended to verify the performance
characteristics of another medicaldevice

ISO 15223-1:2016
Reference no. 5.5.2
ISO 7000:2014
Reference no. 2494

Negative control

Indicates a control material that isintended to verify the results in theexpected negative range

ISO 15223-1:2016
Reference no. 5.5.3
ISO 7000:2014
Reference no. 2495

Positive control

Indicates a control material that isintended to verify the results in theexpected positive range

ISO 15223-1:2016
Reference no. 5.5.4
ISO 7000:2014
Reference no. 2496

SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text

Standard Reference

Contains sufficient for<n> tests

ISO 15223-1:2016
Indicates the total number of IVD
Reference no. 5.5.5
tests that can be performed with theISO 7000:2014
IVD
Reference no. 0518

Patient numberIndicates a unique number
associated with an individual patientISO 15223-1:2016
Reference no. 5.7.1
ISO 7000:2014
Reference no. 2610

This way up

Indicates correct upright position of
the transport package

ISO 780
ISO 7000
Reference no. 0623

Expiration date

Indicates the date after which themedical device is not to be used

Quidel generated symbol
per EDMA

Use-by/expiration date

Indicates the date after which themedical device is not to be used

Quidel generated symbol

Temperature limit

Indicates the temperature limits towhich the medical device can besafely exposed and must be kept inthe dark until use

Quidel generated symbol
per EDMA

Intended use

Indicates the general purpose of adevice

Quidel generated symbol

Prescription use only

Caution: Federal law (USA) restricts
this device to sale by or on the orderof a licensed healthcare practitioner

21 CFR 801.109

Consult e-labeling
instructions for use

Indicates the instructions for use
may be accessed from the Quidel
websiteQuidel generated symbol
per EDMASYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text
Indicates a medical device isintended for research use in theResearch use only
laboratory research phase ofdevelopment; not for therapeutic orin vitro diagnostic use

Standard Reference
Quidel generated symbol
per EDMA
21 CFR 809.10(c)(2)(I)

Indicates a chemical reagent thathas general laboratory application;used to collect, prepare, andexamine specimen from the humanbody for diagnostic purposes

Quidel generated symbol
per EDMA
21 CFR 864.4010

Indicates a potential of fireUS:
29 CFR 1910:1200 (HCS)EU:
Regulation 1272/2008/EC
GHS 02

May intensify fireUS:
29 CFR 1910:1200 (HCS)EU:
Regulation 1272/2008/EC
GHS 03

Indicates a potential of corrosion

US:
29 CFR 1910:1200 (HCS)EU:
Regulation 1272/2008/EC
GHS 05

Toxic if swallowed, inhaled, or
contact with skinUS:
29 CFR 1910:1200 (HCS)EU:
Regulation 1272/2008/EC
GHS 06

Health hazards

Indicates a potential for health risk
to the user of the medical device

US:
29 CFR 1910:1200 (HCS)EU:
Regulation 1272/2008/EC
GHS 07

Serious health hazards

US:
Indicates a potential for serious
29 CFR 1910:1200 (HCS)
health risk to the user of the medical EU:
deviceRegulation 1272/2008/EC
GHS 08General purpose reagent

FlammableOxidizer

Corrosive

Toxic

Environmental or aquatictoxicity

Indicates a potential ofenvironmental or aquatic toxicity

US:29 CFR 1910:1200 (HCS)
EU:Regulation 1272/2008/EC
GHS 09SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text

Standard Reference

Contains/Contents

Indicates the components of aparticular medical device

EDMA Symbols for IVD
Reagents and Components

Contains DMSO

Contains dimethyl sulfoxide, toxic
hazard addressed in the SDS
document

Quidel generated symbol
per EDMAEDMA Symbols for IVDReagents and Components

Contains Evans Blue

Contains Evans Blue, toxic hazard
addressed in the SDS document

EDMA Symbols for IVD
Reagents and Components

Contains Tween 20

Contains Tween 20, toxic hazard
addressed in the SDS document

EDMA Symbols for IVD
Reagents and Components

Contains sodium azide

Contains sodium azide, toxic hazard
addressed in the SDS document

EDMA Symbols for IVD
Reagents and Components

Contains 1% sodiumazide

Contains 0.1% sodium azide, toxic
hazard addressed in the SDS
document

EDMA Symbols for IVD
Reagents and Components

Contains 4% sodiumazide

Contains 4% sodium azide, toxic
hazard addressed in the SDS
document.

EDMA Symbols for IVD
Reagents and Components

Reconstitute with

Reconstitute with 20-mLof Acetone

Instructs the end-user that thecontents of the package requires
dilution; directs end-user to refer toproduct insert for additional
information, e.g., dilution medium
and volume.
Instructs the end-user that thecontents of the package requires
dilution; directs end-user to refer toproduct insert for additional
information, e.g., dilution medium(Acetone) and volume (20-mL)

EDMA Symbols for IVD
Reagents and Components

EDMA Symbols for IVD
Reagents and Components

SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text

Standard Reference

Control 1

Indicates Control 1

ISO 15223-1:2016
Clause 5.2

Control 2

Indicates Control 2

ISO 15223-1:2016
Clause 5.2

Control 3

Indicates Control 3

ISO 15223-1:2016
Clause 5.2

Calibrator

Indicates Calibrator

EDMA Symbols for IVD
Reagents and Components

Calibrator S0

Indicates Calibrator S0

EDMA Symbols for IVD
Reagents and Components

Calibrator S1

Indicates Calibrator S1

EDMA Symbols for IVD
Reagents and Components

Calibrator S2

Indicates Calibrator S2

EDMA Symbols for IVD
Reagents and Components

Calibrator S3

Indicates Calibrator S3

EDMA Symbols for IVD
Reagents and Components

Calibrator S4

Indicates Calibrator S4

EDMA Symbols for IVD
Reagents and Components

SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text

Standard Reference

Calibrator S5

Indicates Calibrator S5

EDMA Symbols for IVD
Reagents and Components

Reagent

Indicates a substance that causes
chemical reactions; used in analysis

EDMA Symbols for IVD
Reagents and Components

Reagent 1a

Indicates Reagent level 1a

EDMA Symbols for IVD
Reagents and Components

Reagent 1b

Indicates Reagent level 1b

EDMA Symbols for IVD
Reagents and Components

Reagent 1c

Indicates Reagent level 1c

EDMA Symbols for IVD
Reagents and Components

Calibration Card

Indicates a Calibration Card

Quidel generated symbol

Quality control card

Indicates a Quality Control Card

Quidel generated symbol

BufferIndicates Buffer

EDMA Symbols for IVD
Reagents and Components

Antibody

Indicates Antibody BNPEDMA Symbols for IVD
Reagents and Components

SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text

Standard Reference

AntibodyIndicates Antibody BNP – alkaline
phosphatase conjugate

EDMA Symbols for IVD
Reagents and Components

Antigen

Indicates Antigen B-Type natriuretic
peptide (BNP)EDMA Symbols for IVD
Reagents and Components

OriginIndicates origin as Mouse

EDMA Symbols for IVD
Reagents and Components

OriginIndicates origin as Human

EDMA Symbols for IVD
Reagents and Components

OriginIndicates origin as Goat

EDMA Symbols for IVD
Reagents and Components

Item number

Indicates the item number

Quidel generated symbol

Part number

Indicates the part number of acomponent

Quidel generated symbol

Test device

Hold the sample from the patient.
Contains reagent zones that cause
reactions to occur to determine
analyte levels in the patient.

Quidel generated symbol

TypeIndicates the type

Quidel generated symbol

SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text

Standard Reference

Quantity

Indicates the quantity

Quidel generated symbol

Medical Device Directive

European Union requirements for
Medical Devices

Quidel generated symbol

Calibration verification

Materials used with a test device toverify the calibration of the test
devices throughout the measurable
range

EDMA Symbols for IVD
Reagents and Components

Expected values

Indicates expected values

Quidel generated symbol

Waste stream disposal
statusDO NOT throw this unit into amunicipal trash bin when this unit
has reached the end of its lifetime.
To ensure utmost protection of theglobal environment and minimize
pollution, please recycle this unit.

Directive 2012/19/EC on
waste electrical andelectronic equipment(WEEE)

Indicates a potential injury to theuser of the medical device

ISO 7010 W001
Graphical symbols -- Safetycolors and safety signs -Part 2: Design principles for
product safety labels

Indicates a potential for burns to theuser of the medical device

ISO 7010 W017
Graphical symbols -- Safetycolors and safety signs -Part 2: Design principles for
product safety labels

Ultraviolet radiation

Indicates a potential for
ultraviolet radiation to the userof the medical device

ISO 7010 W027
Graphical symbols -- Safetycolors and safety signs -Part 2: Design principles for
product safety labels

Potential biohazard

Indicates a potential for healthrisk to the user of the medicaldevice

ISO 7010 W009
Graphical symbols -- Safetycolors and safety signs -Part 2: Design principles for
product safety labels

Warning!

Caution! Hot surface

SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text

Standard Reference
ISO 7010 W004
Graphical symbols -- Safetycolors and safety signs -Part 2: Design principles for
product safety labels

Radiation

Indicates a potential for radiation
exposure to the user of the
medical device

Important

Indicates important information
being conveyed

Quidel generated symbol

CD-RomIndicates that a CD containing
instructions for use is included in akit

Quidel generated symbol

Information

Indicates information of particularimportanceISO 7000:2014
Reference no. 2760

SD CardAny of several kinds to SD cards
bearing information to be
downloaded into a medical device
or saved from a medical device

Quidel generated symbol

China RoHS

Indicates a device does not containany hazardous substances exceeding
concentration limits and is a green
environmentally friendly productwhich can be recycled

China RoHS 2ThawIndicates that the product needs toremain between 19°C to 25°C for adesignated amount of time

Quidel generated symbol

Transfer pipette

Plastic tube with barrel at one end
that is used to transfer sample liquid

Quidel generated graphic

Mean

Indicates average number

ISO 3534-1:2006
Reference 1.15

SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text

Standard ReferenceStandard deviation

Indicates standard deviation

ISO 3534-1:2006
Reference 1.24

CODE CHIP module

Any of several kinds to chips bearing
information to be downloaded intoa medical device

Quidel generated graphic

Printer paper

Paper roll

Quidel generated symbol

Peel open here

Indicates how to open

Quidel generated symbol

Add sample here

Indicates where to add sample
specimen

Quidel generated symbol

Treated human urine
matrixIndicates the type of sample
specimen to be used

Quidel generated symbol

Use EDTA plasma sample
onlyIndicates that an EDTA plasma
sample must be used

Quidel generated symbol

Use urine sample only

Indicates that a urine sample must
be usedQuidel generated symbol

Use EDTA whole blood orplasma sample only

Indicates that an EDTA whole bloodor plasma sample must be used

Quidel generated symbol

SYMBOL GLOSSARY
SymbolExplanation of symbols used in Quidel device labeling.
Symbol Title
Explanatory Text
Add sample immediately
after opening foil pouch

Steps for using a device

Standard Reference

Quidel generated graphic

Standard ReferenceStandard Title

MDD 93/42/EEC

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices

IVDD 98/79/EC

Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998
on in vitro diagnostic medical devices

ISO 15223-1:2016

Medical devices — Symbols to be used with medical device labels, labelling andinformation to be supplied – Part 1: General requirements

ISO 7000:2014

Graphical symbols for use on equipment – registered symbols

ISO 7010:2011

Graphical Symbols – Safety Colours and Safety Signs – Registered safety signs

ISO 780:2015

Packaging – Distribution Packaging – Graphical symbols for handling and storage ofpackages

ISO 3534-1:2006

Statistics Vocabulary and Symbols Part 1: General statistical terms and terms used inprobability

EDMA Symbols for IVD
reagents and components

European Diagnostic Manufacturers Association guidance “EDMA Symbols” for IVD
Reagents and Components, 2009

EDMA Symbols for IVD
reagents and instruments
29 CFR 1910:1200 (HCS)(EC) 1272/2008

European Diagnostic Manufacturers Association guidance “IVD Symbols” for Reagentsand Instruments, 2012
Code of Federal Regulations, Title 29 – Hazard Communication Standard
Regulation on classification, labelling and packaging of substances and mixtures

Directive 2012/19/ECDirective 2012/19/EC on waste electrical and electronic equipment (WEEE)

China RoHS 2

China Restriction of Hazardous Substances 2
GL1018001EN00 (09/18)