SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0099-032-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Pima CD4 test
Assay Type
Flow cytometry
IVD Public Report Category
CD4 technologies
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
Whole blood (venous)
Product Code
Identification name
260100025
Test Package Size
260100100 Pima CD4 100X:
100 Pima CD4 foil sealed test cartridges
260100025 Pima CD4 25X:
25 Pima CD4 foil sealed test cartridges
260300003 Pima Analyser (incl
100 Pima CD4 foil sealed test cartridges
260100025 Pima CD4 25X:
25 Pima CD4 foil sealed test cartridges
260300003 Pima Analyser (incl
Identification name
260100100
Test Package Size
260100100 Pima CD4 100X:
100 Pima CD4 foil sealed test cartridges
260100025 Pima CD4 25X:
25 Pima CD4 foil sealed test cartridges
260300003 Pima Analyser (incl
100 Pima CD4 foil sealed test cartridges
260100025 Pima CD4 25X:
25 Pima CD4 foil sealed test cartridges
260300003 Pima Analyser (incl
Identification name
260300003
Test Package Size
260100100 Pima CD4 100X:
100 Pima CD4 foil sealed test cartridges
260100025 Pima CD4 25X:
25 Pima CD4 foil sealed test cartridges
260300003 Pima Analyser (incl
100 Pima CD4 foil sealed test cartridges
260100025 Pima CD4 25X:
25 Pima CD4 foil sealed test cartridges
260300003 Pima Analyser (incl