SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
12343-021-00
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
Flowflex SARS‐CoV‐2 Antigen Rapid Test (Self‐Testing)
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
SARS-CoV-2 Ag RDT (PQ)
Regulatory Version Submitted To PQ
TGA: ARTG Number;USFDA: 510(k) clearance
Applicant organization
ACON Biotech (Hangzhou) Co Ltd
No. 210 Zhenzhong Road, West Lake District
Hangzhou,
310030
China
Pathogen
SARS-CoV-2
Specimen Type
Swab (nasal)
Product Code
Identification name
L031‐13025
Test kit package size
1
Test Package Size
Test cassette, extraction buffer, swab, waste bag, tube holder, IFU
Identification name
L031‐13035
Test kit package size
2
Test Package Size
2x(Test cassette, extraction buffer, swab, waste bag) + tube holder + 1x IFU
Identification name
L031‐13085
Test kit package size
20
Test Package Size
20x(Test cassette, extraction buffer, swab, waste bag) + tube holder + 1x IFU
Identification name
L031‐13095
Test kit package size
25
Test Package Size
25x(Test cassette, extraction buffer, swab, waste bag) + tube holder + 1x IFU
Identification name
L031‐13045
Test kit package size
3
Test Package Size
3x(Test cassette, extraction buffer, swab, waste bag) + tube holder + 1x IFU
Identification name
L031‐13055
Test kit package size
5
Test Package Size
5x(Test cassette, extraction buffer, swab, waste bag) + tube holder + 1x IFU
Identification name
L031‐13065
Test kit package size
7
Test Package Size
7x(Test cassette, extraction buffer, swab, waste bag) + tube holder + 1x IFU
Identification name
L031‐13075
Test kit package size
10
Test Package Size
10x(Test cassette, extraction buffer, swab, waste bag) + tube holder + 1x IFU