Medical Device Division · registration 240041ActiveSiemens
Hong KongIVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone, Parathyroid Hormone, IntactIVD Class BSiemens Healthcare Diagnostics Inc.
Official record identity
- MDACS listing number
- 240041
- Model name
- Atellica IM Intact Parathyroid Hormone (PTH) (10995621, 10995622), Atellica IM Intact Parathyroid Hormone Master Curve Material (PTH MCM) (10995625), Atellica IM Intact Parathyroid Hormone Quality Control (PTH QC) (10995626)
- 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, Bone Metabolism Hormone, Parathyroid Hormone, Intact
Official value: B
Published parties
- Registrant / registration holder
- Siemens Healthcare Limited
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
Official description
IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Hormone, Parathyroid Hormone, Intact
Additional source fields
- AMD nomenclature code
- 19883
- 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.