SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
13226-013-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Determine Antenatal Care Panel
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV/Syphilis Combo RDT
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
HIV
Syphilis
Specimen Type
Whole blood (capillary)
Product Code
Identification name
CPK-038
Test kit package size
10
Test Package Size
1x 2