Applicant profileRoche Molecular Systems, Inc.
Roche Molecular Systems, Inc.
Hong Kong MDACSUnited States17 registered devicesOct 07, 2011 – Jul 11, 2024
VerifiedMDD (Medical Device Division) · MDACS registry
17
Total devices
3
Risk classes
2011
First registration
2024
Most recent
Applicant overview
- Applicant (EN)
- Roche Molecular Systems, Inc.
- Applicant (ZH)
- Roche Molecular Systems, Inc.
- Country
- United States
- Address
- 1080 US Highway 202 South, Branchburg, New Jersey, 08876, USA
美国
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
Regulatory footprint
Search Roche Molecular Systems, Inc. across other regulatory registries
Thailand
European Union
Colombia
South Korea
Canada
EcuadorRisk class breakdown
B1
C10
D6
Recent MDACS registrations
Latest 15 devices linked to this applicant
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
Jul 11, 2024
- Risk class
- D
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Jul 11, 2024
- Risk class
- D
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Jul 11, 2024
- Risk class
- D
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Jun 04, 2024
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
May 21, 2024
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Apr 18, 2024
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Feb 19, 2024
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Feb 19, 2024
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Feb 19, 2024
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Jan 23, 2024
- Risk class
- B
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Jan 23, 2024
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Jan 23, 2024
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Jan 23, 2024
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Jan 23, 2024
- Risk class
- C
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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
Feb 20, 2018
- Risk class
- D
- Authorised rep
- Roche Diagnostics (Hong Kong) Limited
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.