SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0374-130-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
ARCHITECT HCV Ag assay
Assay Type
IA - Enzyme immunoassay EIA
IVD Public Report Category
HCV serology
Regulatory Version Submitted To PQ
Directive 98/79/EC: Product design examination certificate, Annex IV.4
Applicant organization
Denka Seiken Co., LTD, Kagamida Factory
Denka Seiken Co., Ltd Head Office, 2-1-1, Nihonbashi-Muromachi
Niigata,
959-1695
Japan
Pathogen
HCV
Specimen Type
Plasma
Serum
Product Code
Identification name
03M74-02
Identification name
6L47-02
Identification name
6L47-11
Identification name
6L47-29
Identification name
8C89-01
IVD Manufacturing Site(s)
Denka Seiken Co., LTD, Kagamida Factory
Street 1359-1, Kagamida, Kigoshi, Gosen-shi
Niigata,
959-1695
Japan