SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0348-117-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
STANDARD Q Malaria P.f/P.v Ag Test
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
SD Biosensor, Inc.
16 Deogyeong-daero, 155 beon-gil, Geonggi-do
Suwon-si,
16690
Republic of Korea
Pathogen
Malaria
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
09MAL20D
Test kit package size
25
Test Package Size
25 x aluminim pouch containing a test device + desicant
1 Assay diluent botle (4ml)
25 inverted cup
25 lancets
25 alcohol swab
1 Instructions for Use
1 Assay diluent botle (4ml)
25 inverted cup
25 lancets
25 alcohol swab
1 Instructions for Use
IVD Manufacturing Site(s)
Bionote, Inc (SD Biosensor)
34 Samsung 1ro 4-gill
Hwaseong-si, Gyeongggi-do,
18449
Republic of Korea