FDA Registration
Active
🇳🇴 Norway
Abbott Diagnostics Technologies AS
Reg #: 9613069
·
FEI: 3003045237
·
Expires 2026
Products
11
Proprietary Names
13
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Abbott Diagnostics Technologies AS
- Registration Number
- 9613069
- FEI Number
- 3003045237
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Kjelsaasveien 161
- City
- Oslo
- Country
- NO
Regulatory Submissions
- 510(k) Number
- K151809
Owner / Operator
- Firm Name
- ABBOTT LABORATORIES
- Operator Number
- 1415939
- Address
- 100 ABBOTT PARK RD., D-03Q3, AP52-1
- City
- Abbott Park
- State
- IL
- Postal Code
- 60064
- Country
- US
US Agent
- Business Name
- Alere Inc.
- Contact Name
- Danial Kirmani
- Address
- 150 S. Saunders Road, Landmark of Lake Forest
- City
- Lake Forest
- State
- IL
- ZIP
- 60045
- Country
- US
- [email protected]
- Phone
- 224 4193742
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | Class 1 | Clinical Chemistry | No | 2015-10-26 |
| Assay, Glycosylated Hemoglobin | LCP | Class 2 | Hematology | No | 2015-10-26 |
| Enzymatic Method, Creatinine | JFY | Class 2 | Clinical Chemistry | No | 2018-04-06 |
| Hemoglobin A1c Test System | PDJ | Class 2 | Clinical Chemistry | No | 2019-03-18 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2013-11-21 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2013-11-21 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2013-11-21 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | Class 2 | Immunology | No | 2013-11-21 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2014-05-06 |
| 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 |
Proprietary Names
Afinion HbA1c
Alere Afinion AS100 Analyzer
Afinion ACR
Afinion 2
Afinion HbA1c Dx
Afinion HbA1c Calibration Verification
Afinion HbA1c Control
Afinion ACR Control
Alere Afinion Lipid Panel Control
Alere Afinion Lipid Panel
Alere Afinion AS100 Analyzer
Afinion HbA1c
Afinion 2
Establishment Types
Manufacture Medical Device