SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0458-072-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
SAMBA II HIV-1 Qual Whole Blood Test
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HIV NAT
Regulatory Version Submitted To PQ
Directive 98/79/EC: Product design examination certificate, Annex IV.4
Applicant organization
Diagnostics for the Real World Ltd.
220 Vineyard Ct, Suite 150
Morgan Hill,
California
95037
United States of America
Pathogen
HIV
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
4500-12
Test Package Size
QB II Cartridge 1 (4500A)
QB II Cartridge 2 (4500B)
QB II Cartridge 3 (4500C)
QB II Cartridge 4 (4500D)
QB II Cartridge 2 (4500B)
QB II Cartridge 3 (4500C)
QB II Cartridge 4 (4500D)