EU Manufacturer
🇺🇸 United States
Active
Microgenics Corporation
SRN: US-MF-000030375
·
Kato Road 46500 , 94538 Fremont, United States
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
1
Valid
1
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Kato Road 46500 , 94538 Fremont, United States
- [email protected]
- Phone
- 001-510-979-5000
- Website
- www.thermofisher.com/diagnostics
Regulatory Overview
Regulation
Loading...
Eu Ivdd
5
Classification
Loading...
Eu Ivd General
5
Device Types
Loading...
Certificate Health
Total
1
Valid
1
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDR QMS | HX 1061883-1 | TÜV Rheinland LGA Products GmbH | IVDR | Feb 2024 | Dec 11, 2028 | Supplemented |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CARBAMAZEPINE | EU IVDD | Eu Ivd General | On Market | 0 |
| PHENOBARBITAL | EU IVDD | Eu Ivd General | On Market | 0 |
| PHENYTOIN | EU IVDD | Eu Ivd General | On Market | 0 |
| TDM/DRUG CONTROLS | EU IVDD | Eu Ivd General | On Market | 0 |
| THEOPHYLLINE | EU IVDD | Eu Ivd General | On Market | 0 |