SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
12369-117-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
STANDARD Q COVID-19 Ag Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
SARS-CoV-2 Ag RDT (PQ)
Regulatory Version Submitted To PQ
Directive 98/79/EC: Self-declared CE-mark, Annex III
Applicant organization
SD Biosensor, Inc.
16 Deogyeong-daero, 1556 beon-gil, Geonggi-do
Suwon-si,
16690
Republic of Korea
Pathogen
SARS-CoV-2
Specimen Type
Swab (nasopharyngeal)
Swab (nasal)
Product Code
Identification name
09COV30D
Test kit package size
25
Test Package Size
25 x [test device, extraction buffer tube, nozzle cap, sterile swab] 1 IFU
Identification name
09COV31D
Test kit package size
25
Test Package Size
25 x [test device, extraction buffer tube, nozzle cap, sterile swab (Nasal)] 1 IFU
Identification name
09COV32D
Test kit package size
25
Test Package Size
25 x [test device, extraction buffer tube, nozzle cap, sterile swab, negative and positive control swabs] 1 IFU
Identification name
09COV33D
Test kit package size
25
Test Package Size
25 x [test device, extraction buffer tube, nozzle cap, sterile swab (Nasal), negative and positive control swabs] 1 IFU
Identification name
10COVC11
Test kit package size
10
Test Package Size
10 positive and 10 negative swabs