Medical Device Division · registration 190376ActiveAbbott
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core AntibodyIVD Class DAbbott GmbH & Co. KG
Official record identity
- MDACS listing number
- 190376
- Model name
- Alinity i Anti-HBc II Reagent Kit (07P8722, 07P8732) Alinity i Anti-HBc II Calibrator (07P8701) Alinity i Anti-HBc II Control (07P8710)
- Registration date
- July 24, 2024
- Expiry date
- November 25, 2029
- Source update date
- September 23, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
Official value: D
Published parties
- Registrant / registration holder
- Abbott Laboratories Limited
- Manufacturer
- Abbott GmbH & Co. KG
Official description
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
Additional source fields
- AMD nomenclature code
- 17355
- 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.