Medical Device Division · registration 210423ActiveImmunotech
Hong KongIVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, ThyrotropinIVD Class BImmunotech SAS, A Beckman Coulter Company
Official record identity
- MDACS listing number
- 210423
- Model name
- Access TSH (3rd IS) Reagent Packs (B63284, C28643), Access TSH (3rd IS) Calibrators (B63285)
- Registration date
- September 20, 2024
- Expiry date
- January 17, 2027
- Source update date
- November 05, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin
Official value: B
Published parties
- Registrant / registration holder
- Beckman Coulter Hong Kong Limited
- Manufacturer
- Immunotech SAS, A Beckman Coulter Company
Official description
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin
Additional source fields
- AMD nomenclature code
- 19865
- Traditional Chinese local responsible person
- 貝克曼庫爾特香港有限公司
- Local responsible person phone
- 28147431
- Published manufacturer address
- 130 Avenue de Lattre de Tassigny, BP 177, Marseille, Cedex 9, 13276, France
- 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.