240382
IVD Test Reagent/Kits, Molecular Assay, Control, Targeted Sequencing, Human
体外诊断检测试剂/试剂盒, 分子检测, 对照, 靶向测序, 人类
Microgenics Corporation·C·Hong Kong MDACS·Registered September 11, 2024
Device overview
- Risk class
- C
- Product code
- N/A
- State
- current
- Status
- N/A
Manufacturer (製造商)
- Name
- Microgenics CorporationMicrogenics Corporation
- Country
- United States美国
- Address
- 46500 Kato Road, Fremont CA 94538, USA46500 Kato Road, Fremont CA 94538, 美国
Authorised representative (AR)
- Name
- Thermo Fisher Scientific (Hong Kong) Limited赛默飞世尔科技(香港)有限公司
- Phone
- 31077600
Regulatory timeline
- Registration date
- September 11, 2024
- Expiry date
- September 10, 2029
Product models
AcroMetrix Oncology Hotspot Control (969056)
AcroMetrix Oncology Hotspot Control (969056)
About this record
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Molecular Assay, Control, Targeted Sequencing, Human. 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.