240134
IVD Test Reagent/Kits, Microbiology, Virus, Identification, Cytomegalovirus
体外诊断检测试剂/试剂盒, 微生物学, 病毒, 鉴定, 巨细胞病毒
Roche Molecular Systems, Inc.·C·Hong Kong MDACS·Registered April 18, 2024
Device overview
- Risk class
- C
- Product code
- 19513
- State
- current
- Status
- N/A
- Product code detail
- 19513 IVD Test Reagent/Kits, Microbiology, Virus, Identification, Cytomegalovirus
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, New Jersey, 08876, USA1080 US Highway 202 South, 布兰奇堡, 新泽西州, 08876, 美国
Authorised representative (AR)
- Phone
- 24813387
Regulatory timeline
- Registration date
- April 18, 2024
- Expiry date
- April 17, 2029
Product models
cobas CMV (09040897190), cobas CMV Control Kit (09040919190)
cobas 巨细胞病毒 (09040897190)、cobas 巨细胞病毒对照试剂盒 (09040919190)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Microbiology, Virus, Identification, Cytomegalovirus. 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, Microbiology, Virus, Identification, Cytomegalovirus
產品資訊： 体外诊断检测试剂/试剂盒, 微生物学, 病毒, 鉴定, 巨细胞病毒