IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, DNA

体外诊断检测试剂/试剂盒、分子测定、感染、细菌、沙眼衣原体/淋病奈瑟菌、DNA

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

Device overview

Risk class: C
Product code: 21515
State: current
Status: N/A
Product code detail: 21515 IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, 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, 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 CT/NG Amplification/Detection Kit, 960 Tests (05235979190), cobas 4800 CT/NG Amplification/Detection Kit, 240 Tests (05235952190), cobas 4800 CT/NG Controls Kit (05235928190)

cobas 4800 CT/NG 扩增/检测试剂盒,960 次检测 (05235979190), cobas 4800 CT/NG 扩增/检测试剂盒,240 次检测 (05235952190), cobas 4800 CT/NG 对照试剂盒 (05235928190)

About this record

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, 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, Bacteria, Chlamydia trachomatis/Neisseria gonorrhoeae, DNA

產品資訊： 体外诊断检测试剂/试剂盒、分子测定、感染、细菌、沙眼衣原体/淋病奈瑟菌、DNA