IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, BK Virus, DNA

体外诊断试剂/试剂盒, 分子检测, 感染, 病毒, BK病毒, DNA

Roche Molecular Systems, Inc.·C·Hong Kong MDACS·Registered February 19, 2024

Device overview

Risk class: C
Product code: 22265
State: current
Status: N/A
Product code detail: 22265 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, BK Virus, 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, New Jersey 08876, USA
1080 US Highway 202 South, 布兰奇堡, 新泽西州 08876, 美国

Authorised representative (AR)

Name: Roche Diagnostics (Hong Kong) Limited
Phone: 24813387

Regulatory timeline

Registration date: February 19, 2024
Expiry date: February 18, 2029

Product models

cobas BKV (09040960190), cobas EBV/BKV Control Kit (09040951190)

cobas BKV (09040960190), cobas EBV/BKV 控制套件 (09040951190)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, BK Virus, 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, Virus, BK Virus, DNA

產品資訊： 体外诊断试剂/试剂盒, 分子检测, 感染, 病毒, BK病毒, DNA