SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0321-024-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Paracheck Pf - Rapid Test for P. Falciparum Malaria Device (Ver. 3)
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
Malaria RDT
Regulatory Version Submitted To PQ
Directive 98/79/EC: Self-declared CE-mark, Annex III
Applicant organization
Orchid Biomedical Systems – A Division of Tulip Diagnostics (P) Ltd
Plot nos 88/89, Phase II C, Verna Industrial Estate, Verno,
Goa,
403722
India
Pathogen
Malaria
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
302030005
Test kit package size
5
Test Package Size
buffer
IFU
pictorial procedure
Alcohol swab Pouch
Blood lancet
IFU
pictorial procedure
Alcohol swab Pouch
Blood lancet
Identification name
302030010
Test kit package size
10
Test Package Size
buffer
IFU
pictorial procedure
Alcohol swab Pouch
Blood lancet
IFU
pictorial procedure
Alcohol swab Pouch
Blood lancet
Identification name
302030025
Test kit package size
25
Test Package Size
buffer
IFU
pictorial procedure
Alcohol swab Pouch
Blood lancet
IFU
pictorial procedure
Alcohol swab Pouch
Blood lancet
Identification name
302030100
Test kit package size
100
Test Package Size
buffer
IFU
pictorial procedure
Alcohol swab Pouch
Blood lancet
IFU
pictorial procedure
Alcohol swab Pouch
Blood lancet
Identification name
302030025(1T)
Test kit package size
25
Test Package Size
Individual pouches, each containing: a
IVD Manufacturing Site(s)
Orchid Biomedical Systems – A Division of Tulip Diagnostics (P) Ltd
Plot nos 88/89, Phase II C, Verna Industrial Estate, Verna,
Goa,
403722
India