Abbott Diagnostics Technologies AS
Oslo, NO
Abbott Diagnostics Technologies AS appears in FDA device records in Oslo, NO. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 1 510(k) clearance for Abbott Diagnostics Technologies AS in 2023.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 1 |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613069 | 3003045237 | Abbott Diagnostics Technologies AS | Kjelsaasveien 161, Oslo NO-0884 NO | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LCPAssay, Glycosylated Hemoglobin
- DCKC-Reactive Protein, Antigen, Antiserum, And Control
- JGYColorimetric Method, Triglycerides
- JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- JFYEnzymatic Method, Creatinine
- PDJHemoglobin A1c Test System
- JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)
- LBRLdl & Vldl Precipitation, Hdl
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2736-2024 | Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived. | Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results. | Class II | Open, Classified | |
| Z-2192-2020 | Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway. Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980. The firm name on the label is Alere Technologies AS, Oslo, Norway. | The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain