IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis B

体外诊断检测试剂/试剂盒、分子测定、感染、病毒、乙型肝炎

Roche Molecular Systems, Inc.·D·Hong Kong MDACS·Registered July 11, 2024

Device overview

Risk class: D
Product code: 19243
State: current
Status: N/A
Product code detail: 19243 IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis B

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: July 11, 2024
Expiry date: July 10, 2029

Product models

cobas HBV (09040820190)

乙型肝炎病毒 (09040820190)

About this record

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

產品資訊： 体外诊断检测试剂/试剂盒、分子测定、感染、病毒、乙型肝炎