Medical Device Division · registration 241050ActiveElecsys Total-Tau CSF (08846685190, 08846634190), PreciControl Total-Tau (07357028190), CalSet Total-Tau (07357010190)
Hong KongIVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal FluidIVD Class BRoche Diagnostics GmbH
Official record identity
- MDACS listing number
- 241050
- Model name
- Elecsys Total-Tau CSF (08846685190, 08846634190), PreciControl Total-Tau (07357028190), CalSet Total-Tau (07357010190)
- Registration date
- September 24, 2024
- Expiry date
- September 23, 2029
- Source update date
- February 10, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid
Official value: B
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- Roche Diagnostics GmbH
Official description
IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid
Additional source fields
- AMD nomenclature code
- 17294
- Traditional Chinese local responsible person
- 羅氏診斷(香港)有限公司
- Local responsible person phone
- 24813387
- Published manufacturer address
- Sandhofer Strasse 116, 68305 Mannheim, Germany
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.