Medical Device Division · registration 230295ActiveAbbott Rapid Diagnostic
Hong KongIVD Test Reagent/Kits, Serology, Rapid Test, Virus, Retrovirus, HIV-1/2IVD Class DAbbott Rapid Diagnostics Jena GmbH
Official record identity
- MDACS listing number
- 230295
- Model name
- Panbio HIV Self Test (29012M001)
- Registration date
- December 31, 2025
- Expiry date
- September 12, 2028
- Source update date
- March 04, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Retrovirus, HIV-1/2
Official value: D
Published parties
- Registrant / registration holder
- Abbott Laboratories Limited
- Manufacturer
- Abbott Rapid Diagnostics Jena GmbH
Official description
IVD Test Reagent/Kits, Serology, Rapid Test, Virus, Retrovirus, HIV-1/2
Additional source fields
- AMD nomenclature code
- 19478
- 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
- Revision number
- a
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.