Medical Device Division · registration 240040ActiveSiemens
Hong KongIVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin DIVD Class BSiemens Healthcare Diagnostics Inc.
Official record identity
- MDACS listing number
- 240040
- Model name
- Atellica IM Vitamin D Total (VitD) (10995719, 10995720), Atellica IM Vitamin D Total Quality Control (VitD QC) (10995724), Atellica IM Vitamin D Total Diluent (VitD DIL) (10995721)
- Registration date
- February 06, 2024
- Expiry date
- February 06, 2029
- Source update date
- March 04, 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
- Siemens Healthcare Limited
- Manufacturer
- Siemens Healthcare Diagnostics 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
- 西門子醫療有限公司
- Local responsible person phone
- 25833388
- Published manufacturer address
- 511 Benedict Ave, Tarrytown NY 10591, 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.