240008
IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNA
体外诊断 检测试剂/试剂盒、分子测定、感染、细菌、艰难梭菌、DNA
Roche Molecular Systems, Inc.·B·Hong Kong MDACS·Registered January 23, 2024
Device overview
- Risk class
- B
- Product code
- 34229
- State
- current
- Status
- N/A
- Product code detail
- 34229 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNA
Manufacturer (製造商)
- Name
- Roche Molecular Systems, Inc.Roche Molecular Systems, Inc.
- Country
- United States美国
- Address
- 1080 US Highway 202 South, Branchburg, NJ 08876, USA1080 US Highway 202 South, Branchburg, NJ 08876, USA
Authorised representative (AR)
- Phone
- 24813387
Regulatory timeline
- Registration date
- January 23, 2024
- Expiry date
- January 23, 2029
Product models
cobas 4800 Cdiff Amplification/Detection Kit, 80 Tests (06768237190), cobas 4800 Cdiff Controls and Cofactor Kit (06768300190)
cobas 4800 Cdiff 扩增/检测试剂盒,80 次检测 (06768237190),cobas 4800 Cdiff 对照品和辅因子试剂盒(06768300190)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNA. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.
Product Info: IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNA
產品資訊： 体外诊断 检测试剂/试剂盒、分子测定、感染、细菌、艰难梭菌、DNA