Medical Device Division · registration 240010ActiveRoche Molecular Systems
Hong KongIVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, DNAIVD Class CRoche Molecular Systems, Inc.
Official record identity
- MDACS listing number
- 240010
- Model name
- cobas 4800 CT/NG Amplification/Detection Kit, 960 Tests (05235979190), cobas 4800 CT/NG Amplification/Detection Kit, 240 Tests (05235952190), cobas 4800 CT/NG Controls Kit (05235928190)
- 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 C
- Published category
- IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, DNA
Official value: C
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, Chlamydia trachomatis/Neisseria gonorrhoeae, DNA
Additional source fields
- AMD nomenclature code
- 21515
- 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.