FDA Registration
Active
🇳🇴 Norway
Alere Afinion HbA1c
Reg #: 9613069
·
FEI: 3003045237
·
Expires 2025
Products
7
Proprietary Names
8
Establishment Types
1
Classifications
7
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
- K110056
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 |
|---|---|---|---|---|---|
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2013-11-21 |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | Class 1 | Clinical Chemistry | No | 2013-11-21 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-11-21 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2013-11-21 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2013-11-21 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2013-11-21 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2013-11-21 |
Proprietary Names
Alere Afinion HbA1c
Afinion HbA1c Control
Alere Afinion ACR
Alere Afinion HbA1c Control
Alere Afinion ACR Control
Afinion ACR Control
Afinion HbA1c Calibration Verification
Alere Afinion AS100
Establishment Types
Manufacture Medical Device