Medical Device Division · registration 220019ActiveAbbott Rapid Diagnostics
Hong KongIVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, AntigenIVD Class CAbbott Rapid Diagnostics Jena GmbH
Official record identity
- MDACS listing number
- 220019
- Model name
- Panbio COVID-19 Antigen Self-Test (41FK51, 41FK71, 41FK81, 41FK91)
- Registration date
- January 20, 2022
- Expiry date
- January 20, 2027
- Source update date
- July 10, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
Official value: C
Published parties
- Registrant / registration holder
- Abbott Laboratories Limited
- Manufacturer
- Abbott Rapid Diagnostics Jena GmbH
Official description
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antigen
Additional source fields
- AMD nomenclature code
- 41618
- Traditional Chinese local responsible person
- 美國雅培製藥有限公司
- Local responsible person phone
- 25668711
- Published manufacturer address
- Orlaweg 1, 07743 Jena, GERMANY
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.