SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0563-117-00
Status
Acceptable
Date of prequalification
Basis of listing
EUL
Product name
STANDARD Q COVID-19 Ag Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
SARS-CoV-2 Ag RDT (EUL)
Regulatory Version Submitted To PQ
Directive 98/79/EC: Self-declared CE-mark, Annex III
Applicant organization
SD Biosensor, Inc.
C-4th&5th,16 Deogyeong-daero, 1556 beon-gil, Yeongtong-gu
Suwon-si,
Gyeonggi-do
16690
Republic of Korea
Pathogen
SARS-CoV-2
Specimen Type
Swab (nasopharyngeal)
Swab (nasal)
Product Code
Identification name
09COV30D
Test kit package size
25
Identification name
09COV31D
Test kit package size
25
Identification name
09COV32D
Test kit package size
25
Identification name
10COVC11
Test kit package size
10
Identification name
09COV33D
Test kit package size
25
IVD Manufacturing Site(s)
SD Biosensor, Inc.
16 Deogyeong-daero, 155 beon-gil, Geonggi-do
Suwon-si,
16690
Republic of Korea