FDA Registration
Active
🇺🇸 United States
AcroMetrix HBV Low Control
Reg #: 3010939897
·
FEI: 3010939897
·
Expires 2025
Products
1
Proprietary Names
31
Establishment Types
3
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 |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-06-27 |
Proprietary Names
AcroMetrix HBV Low Control
Alinity i BRAHMS PCT Controls
AcroMetrix Negative Control
Alinity i Anti-Tg Controls
AcroMetrix BKV High Control
AcroMetrix HCV High Control
AcroMetrix HCV Low Control
Alinity i T-Uptake Controls
MAS PTH Control
AcroMetrix BKV Low Control
MAS Diabetes Control
MAS CardioImmune UL
AcroMetrix HBV High Control
AcroMetrix HCV Mid Control
Alinity i Anti-TPO Controls
AcroMetrix HIV-1 High Control
AcroMetrix HIV-1 Mid Control
AcroMetrix HBV Mid Control
MAS Bilirubin Control
Acrometrix BB NAT HBV Positive Control
Acrometrix EV Negative Control
AcroMetrix HIV-1 Low Control
Acrometrix EBV Low Plasma Control
Acrometrix EBV High Plasma Control
DRI THC Urine Controls
Acrometrix EV Low Control
Alinity c Cannabinoids Control 2 Kit
Alinity c Cannabinoids Control 1 Kit
MAS SARS-CoV-2 IgG Positive Control
MAS SARS-CoV-2 Negative Control
MAS Diabetes Max Control
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device