SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0581-117-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
STANDARD G6PD Test
Assay Type
Enzymatic
IVD Public Report Category
G6PD
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
G6PD deficiency
Specimen Type
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
02G6S11
Test kit package size
25
Identification name
02G6S11A
Test kit package size
10