17 Devices

Roche Molecular Systems, Inc. - Applicant Profile

Roche Molecular Systems, Inc.

Roche Molecular Systems, Inc. is associated with 17 medical devices registered under the Hong Kong Medical Device Administrative Control System (MDACS). Explore bilingual product names, risk classes, authorised representatives, and life-cycle milestones.

3 Risk Classes

Since 2011

Latest 2024

Applicant Overview

Bilingual manufacturer details sourced from Hong Kong MDACS.

Applicant (EN)

Roche Molecular Systems, Inc.

Country

United States

美国

Applicant (ZH)

Roche Molecular Systems, Inc.

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

Recent MDACS Registrations

Latest 15 devices linked to this applicant.

Device	Risk Class	Authorised Rep	Registered
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	D	Roche Diagnostics (Hong Kong) Limited	Jul 11, 2024
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Hepatitis C 体外诊断检测试剂/试剂盒、分子测定、感染、病毒、丙型肝炎	D	Roche Diagnostics (Hong Kong) Limited	Jul 11, 2024
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Retrovirus, HIV 体外诊断检测试剂/试剂盒、分子测定、感染、病毒、逆转录病毒、艾滋病毒	D	Roche Diagnostics (Hong Kong) Limited	Jul 11, 2024
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	C	Roche Diagnostics (Hong Kong) Limited	Jun 04, 2024
IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria/Parasite, Mycoplasma Species/Trichomonas vaginalis, DNA 体外诊断检测试剂/试剂盒, 分子检测, 感染, 细菌/寄生虫, 支原体/阴道毛滴虫, DNA	C	Roche Diagnostics (Hong Kong) Limited	May 21, 2024
IVD Test Reagent/Kits, Microbiology, Virus, Identification, Cytomegalovirus 体外诊断检测试剂/试剂盒, 微生物学, 病毒, 鉴定, 巨细胞病毒	C	Roche Diagnostics (Hong Kong) Limited	Apr 18, 2024
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, BK Virus, DNA 体外诊断试剂/试剂盒, 分子检测, 感染, 病毒, BK病毒, DNA	C	Roche Diagnostics (Hong Kong) Limited	Feb 19, 2024
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	C	Roche Diagnostics (Hong Kong) Limited	Feb 19, 2024
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus, DNA 体外诊断试剂/试剂盒,分子测定,感染,病毒,人瘤病毒,DNA	C	Roche Diagnostics (Hong Kong) Limited	Feb 19, 2024
IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Clostridium difficile, DNA 体外诊断检测试剂/试剂盒、分子测定、感染、细菌、艰难梭菌、DNA	B	Roche Diagnostics (Hong Kong) Limited	Jan 23, 2024
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	C	Roche Diagnostics (Hong Kong) Limited	Jan 23, 2024
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	C	Roche Diagnostics (Hong Kong) Limited	Jan 23, 2024
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, Human Papilloma Virus 体外诊断检测试剂/试剂盒、分子检测、感染、病毒、人瘤病毒	C	Roche Diagnostics (Hong Kong) Limited	Jan 23, 2024
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	C	Roche Diagnostics (Hong Kong) Limited	Jan 23, 2024
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe IVD检测试剂/试剂盒、分子检测、核酸探针	D	Roche Diagnostics (Hong Kong) Limited	Feb 20, 2018

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Risk Class Breakdown

C10

Timeline

First Registration

Oct 07, 2011

Most Recent

Jul 11, 2024