FDA Registration
Active
🇳🇴 Norway
Gentian Cystatin C Immunoassay
Reg #: 3006801241
·
FEI: 3006801241
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Gentian AS
- Registration Number
- 3006801241
- FEI Number
- 3006801241
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Bjornasveien 5
- City
- Moss Ostfold
- Country
- NO
Regulatory Submissions
- 510(k) Number
- K071388
Owner / Operator
- Firm Name
- Gentian AS
- Operator Number
- 10023325
- Address
- 15696 Oakstand Road
- City
- Poway
- State
- CA
- Postal Code
- 92064
- Country
- US
US Agent
- Business Name
- E4 Consulting
- Contact Name
- Eric S Gruff
- Address
- 15696 Oakstand Rd
- City
- Poway
- State
- CA
- ZIP
- 92064
- Country
- US
- [email protected]
- Phone
- 858 7350320
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Cystatin C | NDY | Class 2 | Clinical Chemistry | No | 2007-11-16 |
Proprietary Names
Gentian Cystatin C Immunoassay
Establishment Types
Manufacture Medical Device