FDA Registration
Active
🇺🇸 United States
MGC Clinical DAU Control Set
Reg #: 3010939897
·
FEI: 3010939897
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Microgenics Corporation
- Registration Number
- 3010939897
- FEI Number
- 3010939897
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 46500 Kato Road
- City
- Fremont
- State
- CA
- ZIP
- 94538
- Country
- US
Owner / Operator
- Firm Name
- Thermo Fisher Scientific
- Operator Number
- 2517925
- Address
- 168 Third Avenue, --
- City
- Waltham
- State
- MA
- Postal Code
- 02451
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Drug Mixture Control Materials | DIF | Class 1 | Clinical Toxicology | No | 2018-11-13 |
Proprietary Names
MGC Clinical DAU Control Set
Alinity c DOA MC III Controls
CEDIA MultiDrug Optional Controls
CEDIA Specialty Control Set
MAS Tox Control
Alinity c Tox Controls
MAS PAR TDM Liquid Assayed Therapeutic Drug Control
MAS DOA Total Liquid Assayed Drugs of Abuse Control
MGC Select DAU Control Set
Siemens QC Toxicology Control
MGC Primary DAU Control Set
Alinity c DOA MC II Controls
Alinity c DOA MC I Controls
Architect Tox Controls
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device