SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0451-013-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Determine HBsAg 2
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HBV 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
HBV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
7D2942
Test kit package size
20
Test Package Size
7D2942 - 20 tests/kit
test card 10 tests x 2 sheets
7D2943 - 100 tests/kit
test card 10 tests x 10 sheets
7D2943 SET
test card 10 tests x 10 sheets
1 bottle (2
test card 10 tests x 2 sheets
7D2943 - 100 tests/kit
test card 10 tests x 10 sheets
7D2943 SET
test card 10 tests x 10 sheets
1 bottle (2
Identification name
7D2943
Test kit package size
100
Test Package Size
7D2942 - 20 tests/kit
test card 10 tests x 2 sheets
7D2943 - 100 tests/kit
test card 10 tests x 10 sheets
7D2943 SET
test card 10 tests x 10 sheets
1 bottle (2
test card 10 tests x 2 sheets
7D2943 - 100 tests/kit
test card 10 tests x 10 sheets
7D2943 SET
test card 10 tests x 10 sheets
1 bottle (2
Identification name
7D2943 SET
Test kit package size
100
Test Package Size
7D2942 - 20 tests/kit
test card 10 tests x 2 sheets
7D2943 - 100 tests/kit
test card 10 tests x 10 sheets
7D2943 SET
test card 10 tests x 10 sheets
1 bottle (2
test card 10 tests x 2 sheets
7D2943 - 100 tests/kit
test card 10 tests x 10 sheets
7D2943 SET
test card 10 tests x 10 sheets
1 bottle (2
IVD Manufacturing Site(s)
Abbott Diagnostics Medical Co., Ltd. (Formely "Alere Medical Co. Ltd.")
357 Matsuhidai, Chiba-ken
Matsudo-shi,
270-2214
Japan