Medical Device Division · registration 240335ActiveBeckman Coulter, Inc.
Hong KongIVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroxin, FreeIVD Class BBeckman Coulter, Inc.
Official record identity
- MDACS listing number
- 240335
- Model name
- Access Free T4 (Reagent Pack) (33880, C76421), Access Free T4 (Calibrators) (33885)
- Registration date
- September 05, 2025
- Expiry date
- August 07, 2029
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroxin, Free
Official value: B
Published parties
- Registrant / registration holder
- Beckman Coulter Hong Kong Limited
- Manufacturer
- Beckman Coulter, Inc.
Official description
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroxin, Free
Additional source fields
- AMD nomenclature code
- 19111
- 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
- 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.