Medical Device Division · registration 140349ActiveAbbott
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Core AntigenIVD Class DAbbott GmbH & Co. KG
Official record identity
- MDACS listing number
- 140349
- Model name
- ARCHITECT HCV Ag Reagent Kit (6L47-27), ARCHITECT HCV Ag Calibrators (6L47-02), ARCHITECT HCV Ag Controls (6L47-11)
- Registration date
- July 24, 2024
- Expiry date
- October 16, 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 C, Core Antigen
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 C, Core Antigen
Additional source fields
- AMD nomenclature code
- 19062
- 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
- b
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.