SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0033-013-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Determine HIV-1/2
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
7D2243
Test kit package size
100
Test Package Size
Alere Determine™ HIV-1/2 Test Cards, IFU
Identification name
7D2342
Test kit package size
20
Test Package Size
Alere Determine™ HIV-1/2 Test Cards
If whole blood test procedure, 1 bottle of Chase Buffer (2
If whole blood test procedure, 1 bottle of Chase Buffer (2
Identification name
7D2343SET
Test kit package size
100
Test Package Size
Test cards(20 cards of 5 tests/card), IFU, Chase buffer, Capillary tubes, plastic, Blood lancets, sterile
Identification name
7D2343SETS
Test kit package size
100
Test Package Size
Test cards (10 cards of 10 tests/card), IFU, Chase buffer, EDTA capillary tubes, glass (7D2222), Blood lancets, sterile (safety)
IVD Manufacturing Site(s)
Abbott Diagnostics Medical Co., Ltd. (Formely "Alere Medical Co. Ltd.")
357 Matsuhidai, Chiba-ken
Matsudo-shi,
270-2214
Japan
Abbott Medical Co. Ltd. Logistics centre
Chiba Logistics Centre 336-17
Matsuhidai, Matsudo-Shi, Chiba,
270-2214
Japan