SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0587-032-00
Status
Acceptable
Date of prequalification
Basis of listing
EUL
Product name
Panbio COVID-19 Ag Rapid Test Device (Nasal)
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
Abbott Rapid Diagnostics Jena GmbH (former Alere Technologies GmbH)
Loebstedter Str. 103-105
Jena,
7743
Germany
Pathogen
SARS-CoV-2
Specimen Type
Swab (nasopharyngeal)
Product Code
Identification name
41FK11
Test kit package size
25
Identification name
41FK21
Test kit package size
25
Test Package Size
The difference between 41FK11 and 41FK21 is that 41FK21 contains 25 Test devices with a 2D barcode printed on the test device
IVD Manufacturing Site(s)
Abbott Rapid Diagnostics Jena GmbH (former Alere Technologies GmbH)
Orlaweg 1
Jena,
7743
Germany