SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0464-074-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
MERISCREEN HIV 1-2 WB
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV serology
Regulatory Version Submitted To PQ
Directive 98/79/EC: Full quality assurance certificate, Annex IV.3
Applicant organization
Meril Diagnostics Pvt. Ltd.
D1-D3, Meril Park, Survey No: 135/2/B & 174/2, Muktanand Marg, Chala
Vapi,
396191
India
Pathogen
HIV
Specimen Type
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
HVWRPD-01
Test kit package size
30
Test Package Size
for each configuration (30pcs or 40pcs for each unindicated)
pouch with test and dessicant
assay buffer bottles 2 x 3ml
capillary tubes
pack insert
alcohol swabs
lancets
pouch with test and dessicant
assay buffer bottles 2 x 3ml
capillary tubes
pack insert
alcohol swabs
lancets
Identification name
HVWRPD-02
Test kit package size
40
Test Package Size
for each configuration (30pcs or 40pcs for each unindicated)
pouch with test and dessicant
assay buffer bottles 2 x 3ml
capillary tubes
pack insert
alcohol swabs
lancets
pouch with test and dessicant
assay buffer bottles 2 x 3ml
capillary tubes
pack insert
alcohol swabs
lancets
IVD Manufacturing Site(s)
Meril Diagnostics Pvt. Ltd.
D1-D3, Meril Park, Survey No: 135/2/B & 174/2, Muktanand Marg, Chala
Vapi,
396191
India