240012
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus
体外诊断 检测试剂/试剂盒、分子检测、感染、病毒、人瘤病毒
Roche Molecular Systems, Inc.·C·Hong Kong MDACS·Registered January 23, 2024
Device overview
- Risk class
- C
- Product code
- 19249
- State
- current
- Status
- N/A
- Product code detail
- 19249 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus
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 HPV Amplification/Detection Kit, 240 Tests (05235901190), cobas 4800 HPV Amplification/Detection Kit, 960 Tests (05235910190), cobas 4800 HPV Controls Kit (05235855190)
cobas 4800 HPV 扩增/检测试剂盒,240 次检测 (05235901190), cobas 4800 HPV 扩增/检测试剂盒,960 次检测 (05235910190), cobas 4800 HPV 对照试剂盒(05235855190)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus. 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, Virus, Human Papilloma Virus
產品資訊： 体外诊断 检测试剂/试剂盒、分子检测、感染、病毒、人瘤病毒