SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0371-017-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Rapid Anti‐HCV Test
Assay Type
Immunofiltration (flow through)
IVD Public Report Category
HCV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
InTec Products, Inc.
332, Xinguang Rd, Xinyang IND.AREA,Haicang
Xiamen,
361022
China
Pathogen
HCV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
ITPW01152-TC25
Test kit package size
25
Identification name
ITPW01152-TC40
Test kit package size
40
Identification name
ITPW01153-TC40
Test kit package size
40
IVD Manufacturing Site(s)
InTec Products, Inc.
332, Xinguang Rd, Xinyang IND.AREA,Haicang
Xiamen,
361022
China