BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ABBOTT DIABETES CARE INC.

    Reg #: 2954323 · FEI: 3002803444 · Expires 2026
    View on FDA
    Products
    17
    Proprietary Names
    120
    Establishment Types
    3
    Classifications
    17

    Registration Details

    Registration Name
    ABBOTT DIABETES CARE INC.
    Registration Number
    2954323
    FEI Number
    3002803444
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    1360 SOUTH LOOP RD.
    City
    ALAMEDA
    State
    CA
    ZIP
    94502
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051213
    PMA Number
    P150021

    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

    Products

    Device Name Product Code
    Glucose Dehydrogenase, Glucose LFR
    System, Test, Blood Glucose, Over The Counter NBW
    Integrated Continuous Glucose Monitoring System, Factory Calibrated QBJ
    Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems QLG
    Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature FMK
    Medical Device Data System OUG
    Multiple Use Blood Lancet For Single Patient Use Only QRL
    Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature QRK
    Nitroprusside, Ketones (Urinary, Non-Quant.) JIN
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Continuous Glucose Monitor Retrospective Data Analysis Software PHV
    Calculator/Data Processing Module, For Clinical Use JQP
    Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter SAF
    Injection Data Capture Device QOG
    Sensor, Glucose, Invasive MDS
    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated PZE
    Continuous Glucose Monitor Secondary Display PJT

    Proprietary Names

    Precision Xtra Blood Glucose Test Strips FreeStyle Libre 2 Flash Glucose Monitoring System FreeStyle Libre 3 Continuous Glucose Monitoring System Instinct sensor Easy Touch Lancing Device CoPilot Health Management System FreeStyle Freedom Lite Blood Glucose Monitoring System FreeStyle Lite Blood Glucose Monitoring System FreeStyle Precision Neo Blood Glucose Test Strips USB Data Cable Docking Station FreeStyle InsuLinx Blood Glucose Monitoring System FreeStyle Blood Glucose Test Strips THE PRECISION / OPTIUM POINT OF CARE BLOOD GLUCOSE TEST STRIPS FreeStyle Precision H Blood Glucose Monitoring System FreeStyle Lancet OPTIUM BLOOD B-KETONE TEST STRIPS PRECISION XTRA BLOOD B-KETONE TEST STRIPS ACE Control (LN 06U8210) Cystatin C Controls (LN 06T3210) Alinity i Total B-HCG Controls (LN 07P5110) Alinity i Estradiol Controls (LN 07P5010) FreeStyle Control Solution Alinity i Total T4 Controls (LN 07P9510) Alinity i 2nd Generation Testosterone Controls (LN 07P6810) Alinity i Intact PTH Controls (LN 08P3111) Alinity i Prolactin Controls (LN 07P6610) Alinity i Free T4 Controls (LN 7P7010) Alinity i TSH Controls (LN 07P4810) Alinity i Insulin Controls (LN 04T7510) Alinity i FSH Controls (LN 07P4910) Alinity i HE4 Controls (LN 08P5010) Lipase NG OC Control 2 (LN 04Y8511) Alinity i Progesterone Controls (LN 08P3610) Alinity i Syphilis TP Controls (LN 07P6010) Alinity i 25-OH Vitamin D Controls (LN 08P4512) Alinity i CA 125 II Controls (LN 08P4910) Alinity c ASO Control I (LN 04S0912) Alinity c Ammonia Controls (LN 08P2210) Alinity i CA 15-3 Controls (LN 08P5110) ARCHITECT STAT High Sensitivity Troponin-I Controls (LN 2R98-10) Alinity i CA 19-9XR Controls (LN 08P3210) Lipase NG OC Control 1 (LN 04Y8510) Alinity i Ferritin Controls (LN 07P6510) Alinity c Lp(a) Control Kit (LN 01R1410) Alinity i Homocysteine Controls (LN 09P2810) Alinity i C-Peptide Controls (LN 09P3610) Alinity i Folate Controls (LN 08P1412) Alinity i B12 Controls (LN 07P6712) Alinity i Anti-Tg Controls (LN 09P3410) Alinity i Active-B12 (Holotranscobalamin) Controls (LN 09P2610) Alinity c ASO Control II (LN 04S0913) Alinity i DHEA-S Controls (LN 09P3710) Alinity c Hemoglobin A1c Controls (LN 08P4310) Alinity i Anti-TPO Controls (LN 09P3510) Alinity c Cannabinoids Control 2 Kit (LN 09P5411) Alinity c Cannabinoids Control 1 Kit (LN 09P5410) Alinity i T-Uptake Controls (LN 08P1210) ARCHITECT Insulin Controls (LN 08K4112) Alinity i Free T3 Controls (LN 07P6910) MediSense Control Solution Alinity i STAT High Sensitivity Troponin-I Controls (LN 04Z2110) GFAP Controls (Alinity i, LN 04W1710) UCH-L1 Controls (Alinity i, LN 04W1910) GFAP Controls (ARCHITECT, LN 4W16-10) Alinity i BRAHMS PCT Controls (LN 01R1810) Alere NT-proBNP for Alinity i Controls (LN 04S7911) Alinity i CMV IgG Controls (LN 07P4212) ACE Control (LN 06U8610) UCH-L1 Controls (ARCHITECT, LN 4W18-10) FreeStyle Libre Pro Software FreeStyle Libre Software LibreView Bigfoot Unity Report FREESTYLE PRECISION PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM Abbott SF Single Use Lancing Device FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Lantus-Glargine Only Bigfoot Unity Diabetes Management System- For Fiasp and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System- For Fiasp and Basaglar Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System - Cap for Fiasp Only Bigfoot Unity Diabetes Management System - Cap for Toujeo Max Only Bigfoot Unity-Mobile App Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Levemir-Tresiba-Degludec Only Bigfoot Unity Program Kit Bigfoot Unity Diabetes Management System - Cap for Basaglar Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Basaglar Only Bigfoot Unity Diabetes Management System - Cap for Novolog-Aspart Only Bigfoot Unity Diabetes Management System - Cap for Humalog-Lispro-Lyumjev Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Basaglar Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Basaglar Only Bigfoot Unity Diabetes Management System- For Fiasp and Toujeo Max Only Bigfoot Unity Diabetes Management System - Cap for Toujeo Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Toujeo Only Bigfoot Unity Diabetes Management System - Cap for Apidra/Admelog Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Levemir-Tresiba-Degludec Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Toujeo Max Only Bigfoot Unity Diabetes Management System- For Fiasp and Lantus-Glargine Only Bigfoot Unity Diabetes Management System- For Humalog-Lispro-Lyumjev and Toujeo Only Bigfoot Unity Diabetes Management System- For Fiasp and Toujeo Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Toujeo Only Bigfoot Unity Diabetes Management System- For Novolog-Aspart and Lantus-Glargine Only Bigfoot Unity Diabetes Management System- For Apidra-Admelog and Lantus -Glargine Only Bigfoot Unity Diabetes Management System - Cap for Lantus-Glargine Only Bigfoot Unity Diabetes Management System - Cap for Levemir FlextTouch/Tresiba-Degludec Only FreeStyle Precision Neo Blood Glucose Monitoring System Precision Xceed Pro Blood Glucose and Ketone Monitoring System Precision PCx Plus Blood Glucose Test Strips Precision Xceed Pro Blood Glucose Test Strips and Precision Xceed Pro Blood B-Ketone Test Strips Relion Ultima Advance Blood Glucose OptiumEZ Blood Glucose Monitoring S FreeStyle Libre Pro Flash Glucose Monitoring System FreeStyle Libre 14 day Flash Glucose Monitoring System FreeStyle Lancing Device II Precision Xtra Advanced Diabetes Ma Precision Xtra Blood Glucose and Ketone Monitoring System LibreLinkUp

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device