Abbott Diagnostics Technologies AS

FDA Device Registration & Listing · Oslo, NO · Registration 9613069

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9613069
FEI Number
3003045237
Entity Name
Abbott Diagnostics Technologies AS
City/State/Country
Oslo, NO
Establishment Address
Kjelsaasveien 161, Oslo NO-0884, NO
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
ABBOTT LABORATORIES (Owner Number: 1415939)
Owner / Operator Contact Address
100 ABBOTT PARK RD., D-03Q3, AP52-1, Abbott Park, IL 60064, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Afinion HbA1c Alere Afinion AS100 Analyzer Afinion HbA1c Afinion ACR Afinion 2 Afinion HbA1c Dx Afinion HbA1c Calibration Verification Alere Afinion AS100 Analyzer Afinion HbA1c Afinion HbA1c Control Afinion ACR Control Afinion ACR Alere Afinion Lipid Panel Control Alere Afinion Lipid Panel Alere Afinion™ AS100 Analyzer Afinion™ HbA1c Afinion™ 2

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica Clinical Chemistry Class 1 862.2400 2015-10-26
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2015-10-26
JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica Clinical Chemistry Class 1 862.2400 2018-04-06
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2018-04-06
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2018-04-06
JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica Clinical Chemistry Class 1 862.2400 2019-03-18
PDJ Hemoglobin A1c Test System Clinical Chemistry Class 2 862.1373 2019-03-18
JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) Clinical Chemistry Class 1 862.1645 2013-11-21
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2013-11-21
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2013-11-21
DCK C-Reactive Protein, Antigen, Antiserum, And Control Immunology Class 2 866.5270 2013-11-21
JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica Clinical Chemistry Class 1 862.2400 2013-11-21
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2013-11-21
JFY Enzymatic Method, Creatinine Clinical Chemistry Class 2 862.1225 2013-11-21
LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry Class 1 862.1475 2014-05-06
JGY Colorimetric Method, Triglycerides Clinical Chemistry Class 1 862.1705 2014-05-06
CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry Class 1 862.1175 2014-05-06
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2014-05-06
JQT Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica Clinical Chemistry Class 1 862.2400 2025-11-17
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2025-11-17

Official Correspondent

No official correspondent registered.

US Agent Details

Danial Kirmani Business: Alere Inc. Email: danial.kirmani@abbott.com Phone: (224) 4193742

Related Public Records

Same Entity

ABBOTT LABORATORIES
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004032053 Abbott S.r.l. Milan Lombardy, IT
3011706799 Abbott Medical Atlanta, GA, US
1628664 ABBOTT LABORATORIES IRVING, TX, US
3023268435 Abbott Automation Solutions GmbH Hamburg, DE
3001883144 St. Jude Medical Brasil Ltda. Belo Horizonte Minas Gerais, BR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K915332 Ciba Corning Diagnostics Corp. MODEL 795 FLUOROMETER/DENSITOMETER 1992-02-18
K920820 Helena Laboratories MODIFICATION COLUMNMATE 1992-08-17
K991850 Biosafe Laboratories, Inc. SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC 1999-11-26
K012065 Wiener Laboratories Saic WIENER LAB. CREATININA CINETICA AA 2001-10-10
K183555 Instrumentation Laboratory CO GEM Premier ChemSTAT 2019-02-16

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0017-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0019-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0020-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0021-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 2000 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 5 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 3 vials each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613069. Last updated year: 2026. Please use registration number 9613069 when referencing this establishment in official correspondence.
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