Medical Device Division · registration 220280ActiveSiemens
Hong KongIVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Thyroglobulin AntibodyIVD Class BSiemens Healthcare Diagnostics Products Limited
Official record identity
- MDACS listing number
- 220280
- Model name
- Atellica IM Anti-Thyroglobulin II(aTgII) (11201759, 11201761), Atellica aTgII Quality Control (aTgII QC) (11201752), Atellica aTgII Master Curve Control (aTgII MCM) (11207151)
- Registration date
- September 20, 2022
- Expiry date
- September 20, 2027
- Source update date
- August 04, 2023
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Thyroglobulin Antibody
Official value: B
Published parties
- Registrant / registration holder
- Siemens Healthcare Limited
- Manufacturer
- Siemens Healthcare Diagnostics Products Limited
Official description
IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Thyroglobulin Antibody
Additional source fields
- AMD nomenclature code
- 17280
- Traditional Chinese local responsible person
- 西門子醫療有限公司
- Local responsible person phone
- 25833388
- Published manufacturer address
- Glyn Rhonwy, Llanberis, Gwynedd, LL55 4EL, United Kingdom
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.