SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0226-032-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
m-PIMA HIV-1/2 Detect
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
Abbott Rapid Diagnostics Jena GmbH (former Alere Technologies GmbH)
Loebstedter Str. 103-105
Jena,
7743
Germany
Pathogen
HIV
Specimen Type
Plasma
Whole blood (venous)
Product Code
Identification name
270110050
Test kit package size
50
Identification name
27030R001