Medical Device Division · registration 220039ActiveBeckman Coulter
Hong KongIVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin DIVD Class BBeckman Coulter, Inc.
Official record identity
- MDACS listing number
- 220039
- Model name
- Access 25(OH) Vitamin D Total (Reagent Pack) (A98856, B24838, C28646), Access 25(OH) Vitamin D Total (Calibrators) (A98857, B24839)
- Registration date
- July 24, 2024
- Expiry date
- February 08, 2027
- Source update date
- August 15, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D
Official value: B
Published parties
- Registrant / registration holder
- Beckman Coulter Hong Kong Limited
- Manufacturer
- Beckman Coulter, Inc.
Official description
IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D
Additional source fields
- AMD nomenclature code
- 19142
- 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, CA 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.