SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0002-002-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
INSTI HIV-1/HIV-2 Antibody Test
Assay Type
Immunofiltration (flow through)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
bioLytical Laboratories Inc.
Unit 1108
Suite 406, 13251 Delf Pl
Suite 406, 13251 Delf Pl
Richmond,
British Columbia
BV V6V 2A2
Canada
Pathogen
HIV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
90-1010
Test kit package size
24
Identification name
90-1013
Test kit package size
24
Identification name
90-1021
Test kit package size
48
Identification name
90-1022
Test kit package size
48
Identification name
90-1038
Test kit package size
48
Identification name
90-1064
Test kit package size
48
IVD Manufacturing Site(s)
bioLytical Laboratories Inc.
Unit 1108 Suite 406, 13251 Delf Pl
Richmond,
British Columbia
V6V 2A2
Canada