IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Respiratory Syncytial Virus/Influenza A/B, RNA

体外诊断检测试剂/试剂盒, 分子检测, 病毒, 呼吸道合胞病毒/甲型/乙型流感, RNA

Roche Molecular Systems, Inc.·C·Hong Kong MDACS·Registered June 04, 2024

Device overview

Risk class: C
Product code: N/A
State: current
Status: N/A

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: June 04, 2024
Expiry date: June 03, 2029

Product models

cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (08160104190), cobas Influenza A/B & RSV Quality Control Kit for use on the cobas Liat System (07402686190)

cobas 甲型/乙型流感和 RSV 核酸检测,用于 cobas Liat 系统 (08160104190),cobas 甲型流感 & RSV 质控试剂盒,用于 cobas Liat 系统 (07402686190)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Respiratory Syncytial Virus/Influenza A/B, RNA. 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.