SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0359-032-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
m-PIMA HIV-1/2 VL
Assay Type
NAT (nucleic acid testing)
IVD Public Report Category
HIV NAT
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Abbott Rapid Diagnostics Jena GmbH (former Alere Technologies GmbH)
Loebstedter Str. 103-105
Jena,
7743
Germany
Pathogen
HIV
Specimen Type
Plasma
Product Code
Identification name
27015‐W50
Test Package Size
also: m-PIMA HIV1/2 VL
Individually pouched HIV‐1/2 cartridge for viral load monitoring
Sample transfer tool
Instruction for use
Individually pouched HIV‐1/2 cartridge for viral load monitoring
Sample transfer tool
Instruction for use
IVD Manufacturing Site(s)
Abbott Rapid Diagnostics Jena GmbH (former Alere Technologies GmbH)
Orlaweg 1
Jena,
7743
Germany