Applicant profile

Roche Molecular Systems, Inc.

Roche Molecular Systems, Inc.
Hong Kong MDACS·United States·17 registered devices·Oct 07, 2011Jul 11, 2024
17
Total devices
3
Risk classes
2011
First registration
2024
Most recent
Applicant overview
Bilingual manufacturer details sourced from Hong Kong MDACS
Applicant (EN)
Roche Molecular Systems, Inc.
Applicant (ZH)
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
Timeline
First registration
Oct 07, 2011
Most recent
Jul 11, 2024
Risk class breakdown
B
1
C
10
D
6
Recent MDACS registrations
Latest 15 devices linked to this applicant
DeviceRisk classAuthorised repRegistered
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
DRoche Diagnostics (Hong Kong) LimitedJul 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
DRoche Diagnostics (Hong Kong) LimitedJul 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
DRoche Diagnostics (Hong Kong) LimitedJul 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
CRoche Diagnostics (Hong Kong) LimitedJun 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
CRoche Diagnostics (Hong Kong) LimitedMay 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
CRoche Diagnostics (Hong Kong) LimitedApr 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
CRoche Diagnostics (Hong Kong) LimitedFeb 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
CRoche Diagnostics (Hong Kong) LimitedFeb 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
CRoche Diagnostics (Hong Kong) LimitedFeb 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
BRoche Diagnostics (Hong Kong) LimitedJan 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
CRoche Diagnostics (Hong Kong) LimitedJan 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
CRoche Diagnostics (Hong Kong) LimitedJan 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
CRoche Diagnostics (Hong Kong) LimitedJan 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
CRoche Diagnostics (Hong Kong) LimitedJan 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
DRoche Diagnostics (Hong Kong) LimitedFeb 20, 2018
About this profile

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.