Home GUDID 07290015003735 Alere Determine HIV-1/2 Ag/Ab Combo
Primary DI 07290015003735
Brand Alere Determine HIV-1/2 Ag/Ab Combo
Company Orgenics Ltd
Model Alere Determine HIV-1/2 Ag/Ab Combo
Catalog number 7D2648
Device description Alere Determine HIV-1/2 Ag/Ab Combo 25 test kit
Published 2014-09-24
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07290015003735 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07290015003735 07290015003735 7290015003735
GMDN Terms# Term, Definition table Term Definition HIV1/HIV2 antigen/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 antigens from and 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.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 600022628 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit true 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# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 07290015003742 Alere Determine HIV-1/2 Ag/Ab Combo Alere Determine HIV-1/2 Ag/Ab Combo 7D2649 2014-09-24 07290015003759 Alere Determine HIV-1/2 Ag/Ab Combo Controls Alere Determine HIV-1/2 Ag/Ab Combo Cont 7D2628 2014-09-24
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