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SYMBOL GLOSSARY
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SYMBOL GLOSSARY, Explanation of symbols used in Quidel device labeling . Symbol Symbol Title Explanatory Text Standard Reference. ISO 15223 1 2016, Sterilized using ethylene Indicates a medical device that has Reference no 5 2 3. oxide been sterilized using ethylene oxide ISO 7000 2014. Reference no 2501, ISO 15223 1 2016, Sterilized using Indicates a medical device that has Reference no 5 2 4. irradiation been sterilized using irradiation ISO 7000 2014. Reference no 2501, ISO 15223 1 2016, Indicates a medical device that can. Reference no 5 3 1, Fragile handle with care be broken or damaged if not.
ISO 7000 2014, handled carefully, Reference no 0621. ISO 15223 1 2016, Indicates a medical device that Reference no 5 3 2. Keep away from sunlight, needs protection from light sources ISO 7000 2014. Reference no 0624, ISO 15223 1 2016, Indicates a medical device that Reference no 5 3 4. Keep dry, needs protection from moisture ISO 7000 2014.
Reference no 0626, ISO 15223 1 2016, Indicates the lower limit of. Lower limit of Reference no 5 3 5, temperature to which the medical. temperature ISO 7000 2014, device can be safely exposed. Reference no 0534, ISO 15223 1 2016, Indicates the upper limit of. Upper limit of Reference no 5 3 6, temperature to which the medical.
temperature ISO 7000 2014, device can be safely exposed. Reference no 0533, ISO 15223 1 2016, Indicates the temperature limits to. Reference no 5 3 7, Temperature limit which the medical device can be. ISO 7000 2014, safely exposed, Reference no 0632. ISO 15223 1 2016, Indicates the range of humidity to.
Reference no 5 3 8, Humidity limitation which the medical device can be. ISO 7000 2014, safely exposed, Reference no 2620. SYMBOL GLOSSARY, Explanation of symbols used in Quidel device labeling . Symbol Symbol Title Explanatory Text Standard Reference. Indicates that an item can be ISO 7000, Recycable. recycled Reference no 1135, ISO 15223 1 2016, Indicates that there are potential.
Reference no 5 4 1, Biological risks biological risks associated with the. ISO 7000 2014, medical device, Reference no 0659. Indicates a medical device that is ISO 15223 1 2016. intended for one use or for use on a Reference no 5 4 2. Do not reuse, single patient during a single ISO 7000 2014. procedure Reference no 1051, ISO 15223 1 2016, Consult instructions for Indicates the need for the user to Reference no 5 4 3. use consult the instructions for use ISO 7000 2014. Reference no 1641, ISO 15223 1 2016, Indicates the need for the user to.
Reference no 5 4 4, Caution consult the instructions for use for. ISO 7000 2014, important cautionary information, Reference no 0434. Indicates a medical device that is, In vitro diagnostic ISO 15223 1 2016. intended to be used as an in vitro, medical device Reference no 5 5 1. diagnostic medical device, Indicates a control material that is ISO 15223 1 2016.
intended to verify the performance Reference no 5 5 2. Control, characteristics of another medical ISO 7000 2014. device Reference no 2494, ISO 15223 1 2016, Indicates a control material that is. Reference no 5 5 3, Negative control intended to verify the results in the. ISO 7000 2014, expected negative range, Reference no 2495. ISO 15223 1 2016, Indicates a control material that is.
Reference no 5 5 4, Positive control intended to verify the results in the. ISO 7000 2014, expected positive range, Reference no 2496. SYMBOL GLOSSARY, Explanation of symbols used in Quidel device labeling . Symbol Symbol Title Explanatory Text Standard Reference. ISO 15223 1 2016, Indicates the total number of IVD. Contains sufficient for Reference no 5 5 5, tests that can be performed with the.
n tests ISO 7000 2014, IVD, Reference no 0518, ISO 15223 1 2016. Indicates a unique number Reference no 5 7 1, Patient number. associated with an individual patient ISO 7000 2014. Reference no 2610, ISO 780, Indicates correct upright position of. This way up ISO 7000, the transport package, Reference no 0623. Indicates the date after which the Quidel generated symbol. Expiration date, medical device is not to be used per EDMA.
Use by Indicates the date after which the, Quidel generated symbol. expiration date medical device is not to be used, Indicates the temperature limits to. which the medical device can be Quidel generated symbol. Temperature limit, safely exposed and must be kept in per EDMA. the dark until use, Indicates the general purpose of a. Intended use Quidel generated symbol, device, Caution Federal law USA restricts.
Prescription use only this device to sale by or on the order 21 CFR 801 109. of a licensed healthcare practitioner, Indicates the instructions for use. Consult e labeling Quidel generated symbol, may be accessed from the Quidel. instructions for use per EDMA, website, SYMBOL GLOSSARY. Explanation of symbols used in Quidel device labeling . Symbol Symbol Title Explanatory Text Standard Reference. Indicates a medical device is, intended for research use in the Quidel generated symbol. Research use only laboratory research phase of per EDMA. development not for therapeutic or 21 CFR 809 10 c 2 I . in vitro diagnostic use, Indicates a chemical reagent that.
has general laboratory application Quidel generated symbol. General purpose reagent used to collect prepare and per EDMA. examine specimen from the human 21 CFR 864 4010, body for diagnostic purposes. US , 29 CFR 1910 1200 HCS , Flammable Indicates a potential of fire EU . Regulation 1272 2008 EC, GHS 02, US , 29 CFR 1910 1200 HCS . Oxidizer May intensify fire EU , Regulation 1272 2008 EC. GHS 03, US , 29 CFR 1910 1200 HCS , Corrosive Indicates a potential of corrosion EU .
Regulation 1272 2008 EC, GHS 05, US , 29 CFR 1910 1200 HCS . Toxic if swallowed inhaled or, Toxic EU , contact with skin. Regulation 1272 2008 EC, GHS 06, US , 29 CFR 1910 1200 HCS . Indicates a potential for health risk, Health hazards EU . to the user of the medical device, Regulation 1272 2008 EC.
GHS 07, US , Indicates a potential for serious 29 CFR 1910 1200 HCS . Serious health hazards health risk to the user of the medical EU . device Regulation 1272 2008 EC, GHS 08, US , 29 CFR 1910 1200 HCS . Environmental or aquatic Indicates a potential of. EU , toxicity environmental or aquatic toxicity, Regulation 1272 2008 EC. GHS 09, SYMBOL GLOSSARY, Explanation of symbols used in Quidel device labeling . Symbol Symbol Title Explanatory Text Standard Reference. Indicates the components of a EDMA Symbols for IVD. Contains Contents, particular medical device Reagents and Components.
Quidel generated symbol, Contains dimethyl sulfoxide toxic. per EDMA, Contains DMSO hazard addressed in the SDS. EDMA Symbols for IVD, document, Reagents and Components. Contains Evans Blue toxic hazard EDMA Symbols for IVD. Contains Evans Blue, addressed in the SDS document Reagents and Components. Contains Tween 20 toxic hazard EDMA Symbols for IVD. Contains Tween 20, addressed in the SDS document Reagents and Components.
Contains sodium azide toxic hazard EDMA Symbols for IVD. Contains sodium azide, addressed in the SDS document Reagents and Components. Contains 0 1 sodium azide toxic, Contains 1 sodium EDMA Symbols for IVD. hazard addressed in the SDS, azide Reagents and Components. document, Contains 4 sodium azide toxic, Contains 4 sodium EDMA Symbols for IVD. hazard addressed in the SDS, azide Reagents and Components.
document , Instructs the end user that the, contents of the package requires. dilution directs end user to refer to EDMA Symbols for IVD. Reconstitute with, product insert for additional Reagents and Components. information e g dilution medium, and volume , Instructs the end user that the. contents of the package requires, Reconstitute with 20 mL dilution directs end user to refer to EDMA Symbols for IVD. of Acetone product insert for additional Reagents and Components. information e g dilution medium, Acetone and volume 20 mL .
SYMBOL GLOSSARY, Explanation of symbols used in Quidel device labeling . Symbol Symbol Title Explanatory Text Standard Reference. ISO 15223 1 2016, Control 1 Indicates Control 1, Clause 5 2. ISO 15223 1 2016, Control 2 Indicates Control 2, Clause 5 2. ISO 15223 1 2016, Control 3 Indicates Control 3, Clause 5 2. EDMA Symbols for IVD, Calibrator Indicates Calibrator.
Reagents and Components, EDMA Symbols for IVD, Calibrator S0 Indicates Calibrator S0. Reagents and Components, EDMA Symbols for IVD, Calibrator S1 Indicates Calibrator S1. Reagents and Components, EDMA Symbols for IVD, Calibrator S2 Indicates Calibrator S2. Reagents and Components, EDMA Symbols for IVD, Calibrator S3 Indicates Calibrator S3. Reagents and Components, EDMA Symbols for IVD, Calibrator S4 Indicates Calibrator S4.
Reagents and Components, SYMBOL GLOSSARY, Explanation of symbols used in Quidel device labeling . Symbol Symbol Title Explanatory Text Standard Reference. EDMA Symbols for IVD, Calibrator S5 Indicates Calibrator S5. Reagents and Components, Indicates a substance that causes EDMA Symbols for IVD. Reagent, chemical reactions used in analysis Reagents and Components. EDMA Symbols for IVD, Reagent 1a Indicates Reagent level 1a.
Reagents and Components, EDMA Symbols for IVD, Reagent 1b Indicates Reagent level 1b. Reagents and Components, EDMA Symbols for IVD, Reagent 1c Indicates Reagent level 1c. Reagents and Components, Calibration Card Indicates a Calibration Card Quidel generated symbol. Quality control card Indicates a Quality Control Card Quidel generated symbol. EDMA Symbols for IVD, Buffer Indicates Buffer, Reagents and Components. EDMA Symbols for IVD, Antibody Indicates Antibody BNP.
Reagents and Components, SYMBOL GLOSSARY, Explanation of symbols used in Quidel device labeling . Symbol Symbol Title Explanatory Text Standard Reference. Indicates Antibody BNP alkaline EDMA Symbols for IVD. Antibody, phosphatase conjugate Reagents and Components. Indicates Antigen B Type natriuretic EDMA Symbols for IVD. Antigen, peptide BNP Reagents and Components, EDMA Symbols for IVD. Origin Indicates origin as Mouse, Reagents and Components. EDMA Symbols for IVD, Origin Indicates origin as Human.
Reagents and Components, EDMA Symbols for IVD, Origin Indicates origin as Goat. Reagents and Components, Item number Indicates the item number Quidel generated symbol. Indicates the part number of a, Part number Quidel generated symbol. component, Hold the sample from the patient , Contains reagent zones that cause. Test device Quidel generated symbol, reactions to occur to determine.
analyte levels in the patient , Type Indicates the type Quidel generated symbol. SYMBOL GLOSSARY, Explanation of symbols used in Quidel device labeling . Symbol Symbol Title Explanatory Text Standard Reference. Quantity Indicates the quantity Quidel generated symbol. European Union requirements for, Medical Device Directive Quidel generated symbol. Medical Devices, Materials used with a test device to. verify the calibration of the test EDMA Symbols for IVD. Calibration verification, devices throughout the measurable Reagents and Components.
range, Expected values Indicates expected values Quidel generated symbol. DO NOT throw this unit into a, municipal trash bin when this unit Directive 2012 19 EC on. Waste stream disposal has reached the end of its lifetime waste electrical and. status To ensure utmost protection of the electronic equipment. global environment and minimize WEEE , pollution please recycle this unit . ISO 7010 W001, Graphical symbols Safety, Indicates a potential injury to the. Warning colors and safety signs , user of the medical device.
Part 2 Design principles for, product safety labels. ISO 7010 W017, Graphical symbols Safety, Caution Hot surface Indicates a potential for burns to the. colors and safety signs , user of the medical device. Part 2 Design principles for, product safety labels. ISO 7010 W027, Indicates a potential for Graphical symbols Safety.
Ultraviolet radiation ultraviolet radiation to the user colors and safety signs . of the medical device Part 2 Design principles for. product safety labels, ISO 7010 W009, Indicates a potential for health Graphical symbols Safety. Potential biohazard risk to the user of the medical colors and safety signs . device Part 2 Design principles for, product safety labels. SYMBOL GLOSSARY, Explanation of symbols used in Quidel device labeling . Symbol Symbol Title Explanatory Text Standard Reference. ISO 7010 W004, Indicates a potential for radiation Graphical symbols Safe. ISO 7000 Reference no 1135 Reference no 0659 Biological risks Indicates that there are potential biological risks associated with the medical device ISO 15223 1 2016 Reference no 5 4 1 ISO 7000 2014 Do not reuse Indicates a medical device that is intended for one use or for use on a single patient during a single procedure ISO 15223 1 2016

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