Medical Device Division · registration 240008ActiveRoche Molecular Systems
Hong KongIVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNAIVD Class BRoche Molecular Systems, Inc.
Official record identity
- MDACS listing number
- 240008
- Model name
- cobas 4800 Cdiff Amplification/Detection Kit, 80 Tests (06768237190), cobas 4800 Cdiff Controls and Cofactor Kit (06768300190)
- Registration date
- January 23, 2024
- Expiry date
- January 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, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNA
Official value: B
Published parties
- Registrant / registration holder
- Roche Diagnostics (Hong Kong) Limited
- Manufacturer
- Roche Molecular Systems, Inc.
Official description
IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNA
Additional source fields
- AMD nomenclature code
- 34229
- Traditional Chinese local responsible person
- 羅氏診斷(香港)有限公司
- Local responsible person phone
- 24813387
- Published manufacturer address
- 1080 US Highway 202 South, Branchburg, NJ 08876, 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.