FDA Registration
Active
🇺🇸 United States
CEDIA Methamphetamine OFT Controls
Reg #: 3010939897
·
FEI: 3010939897
·
Expires 2025
Products
1
Proprietary Names
16
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 Specific Control Materials | LAS | Class 1 | Clinical Toxicology | No | 2017-06-01 |
Proprietary Names
CEDIA Methamphetamine OFT Controls
CEDIA THC OFT Controls
DRI MDA Control
QMS Zonisamide Control
QMS Plazomicin Immunoassay Control
DRI Oxycodone Control Set 100
QMS Lamotrigine Control
MAS Mycophenolic Acid Liquid Assayed Mycophenolic Acid Controls
CEDIA Buprenorphine Controls
CEDIA Buprenorphine II Control
MGC Cyclosporine PLUS Control
QMS Everolimus Control
QMS Topiramate Control
DRI Hydrocodone Assay Control Kit
DRI Oxycodone Control Set 300
CEDIA DAU THC Control Set
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device