SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0243-013-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Determine HIV Early Detect
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Abbott Diagnostics Medical Co., Ltd. (Formely: Alere Medical Co. Ltd.)
357 Matsuhidai, Chiba-ken
Matsudo-shi,
270-2214
Japan
Pathogen
HIV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
7D2842
Test kit package size
20
Test Package Size
Contains:
Alere HIV Combo Test Card, 2 or 10 cards (10 tests/card) coated with HIV-1/2 recombiant antigen, synthetic peptides, anti-p24 antibodies and avidin
Alere HIV Combo Test Card, 2 or 10 cards (10 tests/card) coated with HIV-1/2 recombiant antigen, synthetic peptides, anti-p24 antibodies and avidin
Identification name
7D2843
Test kit package size
100
Test Package Size
Contains:
Alere HIV Combo Test Card, 2 or 10 cards (10 tests/card) coated with HIV-1/2 recombiant antigen, synthetic peptides, anti-p24 antibodies and avidin
Alere HIV Combo Test Card, 2 or 10 cards (10 tests/card) coated with HIV-1/2 recombiant antigen, synthetic peptides, anti-p24 antibodies and avidin
Identification name
7D2843SET
Test kit package size
100
Test Package Size
Determine HIV Early Detect Test Card, IFU, Chase Buffer, prepared in phosphate buffer (7D2243), Capillary tubes, plastic, Blood lancets, sterile
IVD Manufacturing Site(s)
Abbott Medical Co. Ltd. Logistics centre
Chiba Logistics Centre 336-17
Matsuhidai, Matsudo-Shi, Chiba,
270-2214
Japan
Abbott Diagnostics Medical Co., Ltd. (Formely "Alere Medical Co. Ltd.")
357 Matsuhidai, Chiba-ken
Matsudo-shi,
270-2214
Japan