Medical Device Division · registration 220422ActiveAbbott GmbH
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis C, AntibodyIVD Class DAbbott GmbH
Official record identity
- MDACS listing number
- 220422
- Model name
- Alinity s Anti-HCV II Reagent kit (04W5656), Alinity s Anti-HCV II Release Control kit (04W5612), Alinity s Anti-HCV II Assay Control Kit (04W5610), Alinity s Anti-HCV II Calibrator Kit (04W5602)
- Registration date
- April 16, 2025
- Expiry date
- January 03, 2028
- Source update date
- July 30, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody
Official value: D
Published parties
- Registrant / registration holder
- Abbott Laboratories Limited
- Manufacturer
- Abbott GmbH
Official description
IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody
Additional source fields
- AMD nomenclature code
- 17914
- Traditional Chinese local responsible person
- 美國雅培製藥有限公司
- Local responsible person phone
- 25668711
- Published manufacturer address
- Max-Planck-Ring 2, 65205 Wiesbaden, 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.