FDA Registration
Active
🇸🇪 Sweden
Miris Calibration Control Kit
Reg #: 3013887826
·
FEI: 3013887826
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MIRIS AB
- Registration Number
- 3013887826
- FEI Number
- 3013887826
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Danmarksgatan 26
- City
- Uppsala
- Country
- SE
Owner / Operator
- Firm Name
- Miris AB
- Operator Number
- 10059205
- Address
- Danmarksgatan 26
- City
- Uppsala
- State
- SE-C
- Postal Code
- 75323
- Country
- SE
US Agent
- Business Name
- mdi Consultants Inc
- Contact Name
- Alan Schwartz
- Address
- 55 Northern Blvd
- City
- Great Neck
- State
- NY
- ZIP
- 11021
- Country
- US
- [email protected]
- Phone
- 516 4829001
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Multi-Analyte Controls Unassayed | OHQ | Class 1 | Clinical Chemistry | No | 2019-04-26 |
Proprietary Names
Miris Calibration Control Kit
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198