Medical Device Division · registration 240336ActiveBeckman Coulter, Inc.
Hong KongIVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125IVD Class CBeckman Coulter, Inc.
Official record identity
- MDACS listing number
- 240336
- Model name
- Access OV Monitor (Reagent Pack) (386357), Access OV Monitor (Calibrators) (386358)
- Registration date
- August 08, 2024
- Expiry date
- August 07, 2029
- Source update date
- September 23, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125
Official value: C
Published parties
- Registrant / registration holder
- Beckman Coulter Hong Kong Limited
- Manufacturer
- Beckman Coulter, Inc.
Official description
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125
Additional source fields
- AMD nomenclature code
- 19104
- 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
- 250 South Kraemer Blvd., Brea, California, 92821, USA
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.