Medical Device Division · registration 240382ActiveMicrogenics
Hong KongIVD Test Reagent/Kits, Molecular Assay, Control, Targeted Sequencing, HumanIVD Class CMicrogenics Corporation
Official record identity
- MDACS listing number
- 240382
- Model name
- AcroMetrix Oncology Hotspot Control (969056)
- Registration date
- September 11, 2024
- Expiry date
- September 10, 2029
- Source update date
- March 25, 2025
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class C
- Published category
- IVD Test Reagent/Kits, Molecular Assay, Control, Targeted Sequencing, Human
Official value: C
Published parties
- Registrant / registration holder
- Thermo Fisher Scientific (Hong Kong) Limited
- Manufacturer
- Microgenics Corporation
Official description
IVD Test Reagent/Kits, Molecular Assay, Control, Targeted Sequencing, Human
Additional source fields
- AMD nomenclature code
- 42308
- Traditional Chinese local responsible person
- 賽默飛世爾科技(香港)有限公司
- Local responsible person phone
- 31077600
- Published manufacturer address
- 46500 Kato Road, Fremont CA 94538, USA
About this record
This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.