Medical Device Division · registration 240339ActiveMicrogenics Corporation
Hong KongIVD Test Reagent/Kits, Clinical Chemistry, Alcohol LevelIVD Class BMicrogenics Corporation
Official record identity
- MDACS listing number
- 240339
- Model name
- DRI Ethyl Alcohol Assay (10016397, 0037, 0038), DRI Negative Alcohol Calibrator (0311, 1405), DRI 100 mg/dL Alcohol Calibrator (0241, 1406), DRI 50 mg/dL Alcohol Control (0239), DRI 300 mg/dL Alcohol Control (0243)
- Registration date
- August 08, 2024
- Expiry date
- August 07, 2029
- Source update date
- October 02, 2024
- Status
- Active
Official value: Valid
Classification
- Risk class
- IVD Class B
- Published category
- IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level
Official value: B
Published parties
- Registrant / registration holder
- Thermo Fisher Scientific (Hong Kong) Limited
- Manufacturer
- Microgenics Corporation
Official description
IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level
Additional source fields
- AMD nomenclature code
- 18930
- 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.