SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
13194-160-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
BIOCREDIT Malaria Ag Pf/Pv (pLDH/pLDH)
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
Malaria RDT
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
Rapigen, Inc.
161, Saneop-ro 155 beon-gil, Gwonseon-gu Suwon-si
Gyeonggi-do,
16648
Republic of Korea
Pathogen
Malaria
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
C61RHG25
Test kit package size
25
Test Package Size
all accessories
Identification name
C61RHH25
Test kit package size
25
Test Package Size
all accessories including sterile lancet and pair of gloves