Home GUDID 00608337000016 OraQuick Advance Rapid HIV 1/2 Antibody Test
Primary DI 00608337000016
Brand OraQuick Advance Rapid HIV 1/2 Antibody Test
Company Orasure Technologies, Inc.
Model 3001-1197
Published 2014-09-05
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name MTL Monitor,Test,Hiv-1
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MTL Monitor,Test,Hiv-1 Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10608337000013 Package GS1 100 In Commercial Distribution 20608337000010 Package GS1 25 In Commercial Distribution 00608337000016 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10608337000013 10608337000013 20608337000010 20608337000010 00608337000016 00608337000016 608337000016 0608337000016
GMDN Terms# Term, Definition table Term Definition HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to human immunodeficiency virus 1 and 2 (HIV1/HIV2) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses and may be available [non-prescription] over-the-counter (OTC) for self-testing by a layperson in the home or similar environment.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 27 Degrees Celsius
Regulatory Flags# DUNS number 114152184 Device count 1 DM exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00817169024880 3D Dental 3D DENTAL DESIGNS AND DEVELOPMENT, LLC MTL 2023-01-10 00875197000993 COBAS AMPLICOR HIV-1 Monitor Test, version 1.5 Roche Molecular Systems, Inc. MTL 2014-09-17 00608337000009 OraQuick Advance HIV 1/2 Kit Controls Orasure Technologies, Inc. MTL 2014-09-05 20608337000010 OraQuick Advance Rapid HIV 1/2 Antibody Test Orasure Technologies, Inc. MTL 2014-09-05
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