IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant

体外诊断检测试剂/试剂盒、分子测定、感染、细菌、金黄色葡萄球菌、DNA、抗菌耐药性

Roche Molecular Systems, Inc.·C·Hong Kong MDACS·Registered January 23, 2024

Device overview

Risk class: C
Product code: 21666
State: current
Status: N/A
Product code detail: 21666 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant

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, NJ 08876, USA
1080 US Highway 202 South, Branchburg, NJ 08876, USA

Authorised representative (AR)

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

Regulatory timeline

Registration date: January 23, 2024
Expiry date: January 23, 2029

Product models

cobas 4800 MRSA/SA Amplification/Detection Kit, 240 Tests (06768172190), cobas 4800 MRSA/SA Amplification/Detection Kit, 80 Tests (06768113190), cobas 4800 MRSA/SA Controls and Cofactor Kit (06768288190)

cobas 4800 MRSA/SA 扩增/检测试剂盒,240 次检测 (06768172190),cobas 4800 MRSA/SA 扩增/检测试剂盒,80 次检测 (06768113190),cobas 4800 MRSA/SA 对照品和辅因子试剂盒(06768288190)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant. 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, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant

產品資訊： 体外诊断检测试剂/试剂盒、分子测定、感染、细菌、金黄色葡萄球菌、DNA、抗菌耐药性