IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Epstein-Barr, DNA

体外诊断试剂/试剂盒, 分子检测, 感染, 病毒, EB病毒, DNA

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

Device overview

Risk class: C
Product code: 22282
State: current
Status: N/A
Product code detail: 22282 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Epstein-Barr, 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 EBV (09040943190)

About this record

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

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