Medical Device Division · registration 210398ActiveBeckman Coulter
Hong KongIVD Test Reagent/Kits, Immunoassay, Protein, ProcalcitoninIVD Class BImmunotech SAS, A Beckman Coulter Company
Official record identity
- MDACS listing number
- 210398
- Model name
- Access PCT (Reagent Pack) (C22593), Access PCT (Calibrators) (C22594)
- Registration date
- March 26, 2026
- Expiry date
- December 02, 2031
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitonin
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, Protein, Procalcitonin
Additional source fields
- AMD nomenclature code
- 25106
- 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
- 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.