FDA Registration
Active
🇳🇴 Norway
Afinion ACR
Reg #: 9613069
·
FEI: 3003045237
·
Expires 2025
Products
3
Proprietary Names
5
Establishment Types
1
Classifications
3
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
- K171650
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 |
|---|---|---|---|---|---|
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | Class 1 | Clinical Chemistry | No | 2018-04-06 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2018-04-06 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2018-04-06 |
Proprietary Names
Afinion ACR
Alere Afinion HbA1c
Afinion 2
Alere Afinion ACR
Afinion HbA1c
Establishment Types
Manufacture Medical Device