Medical Device Division · registration 240062ActiveAbbott
Hong KongIVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core AntibodyIVD Class DAbbott GmbH
Official record identity
- MDACS listing number
- 240062
- Model name
- ARCHITECT Anti-HBc IgM Calibrators (6C33-02), ARCHITECT Anti-HBc IgM Controls (6C33-11), ARCHITECT Anti-HBc IgM Reagent Kit (6C33-22, 6C33-27)
- Registration date
- February 19, 2024
- Expiry date
- February 18, 2029
- Source update date
- July 15, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class D
- Published category
- IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core Antibody
Official value: D
Published parties
- Registrant / registration holder
- Abbott Laboratories Limited
- Manufacturer
- Abbott GmbH
Official description
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, IgM Core Antibody
Additional source fields
- AMD nomenclature code
- 17356
- 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
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.