FDA Registration
Active
🇺🇸 United States
DRI Methaqualone Assay
Reg #: 3010939897
·
FEI: 3010939897
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
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
Regulatory Submissions
- 510(k) Number
- K940123
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 |
|---|---|---|---|---|---|
| Radioimmunoassay, Methaqualone | KXS | Class 2 | Clinical Toxicology | No | 2008-02-27 |
Proprietary Names
DRI Methaqualone Assay
Establishment Types
Manufacture Medical Device