Home GUDID 20608337000010 OraQuick Advance Rapid HIV 1/2 Antibody Test
Primary DI 20608337000010
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
OTC false
Sterile false
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 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 Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 00608337000016 OraQuick Advance Rapid HIV 1/2 Antibody Test Orasure Technologies, Inc. MTL 2014-09-05 00608337000009 OraQuick Advance HIV 1/2 Kit Controls Orasure Technologies, Inc. MTL 2014-09-05
orasure.com