FDA Registration
Active
🇳🇴 Norway
Alere Afinion Lipid Panel
Reg #: 9613069
·
FEI: 3003045237
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Abbott Diagnostics Technologies AS
- Registration Number
- 9613069
- FEI Number
- 3003045237
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kjelsaasveien 161
- City
- OSLO
- Country
- NO
Regulatory Submissions
- 510(k) Number
- K132031
Owner / Operator
- Firm Name
- Abbott
- Operator Number
- 9006731
- Address
- 100 Abbott Park Road, Dept. RX51/J55/MS 6134
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2014-05-06 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2014-05-06 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2014-05-06 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2014-05-06 |
Proprietary Names
Alere Afinion Lipid Panel
Alere Afinion Lipid Panel Control
Establishment Types
Manufacture Medical Device