BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    AXIS-SHIELD DIAGNOSTICS, LTD.

    Reg #: 8032314 · FEI: 3002808140 · Expires 2026
    View on FDA
    Products
    14
    Proprietary Names
    49
    Establishment Types
    2
    Classifications
    14

    Registration Details

    Registration Name
    AXIS-SHIELD DIAGNOSTICS, LTD.
    Registration Number
    8032314
    FEI Number
    3002808140
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    LUNA PLACE, THE TECHNOLOGY PARK
    City
    DUNDEE Scotland
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K233541

    Owner / Operator

    Firm Name
    AXIS-SHIELD DIAGNOSTICS, LTD.
    Operator Number
    8032314
    Address
    LUNA PLACE, THE TECHNOLOGY PARK
    City
    DUNDEE, SCOTLAND
    State
    GB-NOTA
    Postal Code
    DD2 1XA
    Country
    GB

    US Agent

    Business Name
    Abbott Laboratories
    Contact Name
    Danial Kirmani
    Address
    Dept. Rx51/J55/Ms 6134, 100 Abbott Park Rd
    City
    North Chicago
    State
    IL
    ZIP
    60064
    Country
    US
    Email
    [email protected]
    Phone
    224 6686318

    Products

    Device Name Product Code
    Multi-Analyte Controls, All Kinds (Assayed) JJY
    Radioassay, Vitamin B12 CDD
    Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) NHX
    Urinary Homocystine (Nonquantitative) Test System LPS
    Single (Specified) Analyte Controls (Assayed And Unassayed) JJX
    Interleukin 6 QLC
    Calibrator, Secondary JIT
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    Assay, Erythropoietin GGT
    Test, Natriuretic Peptide NBC
    Calibrator, Multi-Analyte Mixture JIX
    Lipoprotein, Low-Density, Antigen, Antiserum, Control DFC
    Antigens, Nontreponemal, All GMQ
    Radioimmunoassay, Calcitonin JKR

    Proprietary Names

    Cholestech LDX Multianalyte Calibration Verification Cholestech LDX Multianalyte Controls (2x2mL) Cholestech LDX Multianalyte Controls (2x 250uL) ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) assay ARCHITECT Active-B12 (Holotranscobalamin) Alinity Active-B12 (Holotranscobalamin) ADVIA Centaur anti-CCP (aCCP) assay ADVIA Centaur anti-CCP (aCCP) Quality Controls ADVIA Centaur anti-CCP (aCCP) Master Curve Materials (MCM) 3-Reagent Homocysteine Assay for SYNCHRON and UniCel Alinity I 2nd Generation Testosterone Controls Alinity i Active-B12 (Holotranscobalamin) Controls Afinion HbA1c Control Atellica IM Lipopolysaccharide Binding Protein Quality Control Alere NT-proBNP for Alinity i Control ADVIA Centaur Lipopolysaccharide Binding Protein (LBP) Quality Control SMN 10995083 - ADVIA Centaur® IL6 Quality Control Material SMN 10995080 - ADVIA Centaur® IL6 Assay Atellica IM Interleukin-6 Quality Control Atellica IM Interleukin-6 (IL6) ABBOTT ARCHITECT 2nd Generation Testosterone Axis-Shield Active-B12 (Holotranscobalmin) ADVIA Centaur Erythropoietin (EPO) Assay (XP) Ortho Clinical Diagnostics Vitros Homocysteine Alere NT-proBNP for Alinity i Alinity I 2nd Generation Testosterone Calibrators Alinity i Active-B12 (Holotranscobalamin) Calibrators AFINION™ HbA1c Calibration Verification Alere NT-proBNP for Alinity i Calibrators ARCHITECT 2nd Generation Testosterone Alinity i 2nd Generation Testosterone Reagent Kit N Latex HCY ARCHITECT Anti-CCP Controls Alinity I Anti-CCP Controls Alinity I Anti-CCP Calibrators AXIS SHIELD Homocysteine Control Kit (FHCY200/ B08177) ABBOTT ARCHITECT Homocysteine Alinity i Active-B12 (Holotranscobalamin) ABBOTT ARCHITECT Active-B12 (Holotranscobalamin) Gold Standard Diagnostics AIX1000 Rapid Plasma Reagin (RPR) Automated Test System ADVIA Centaur® Calcitonin (CALCT) assay Alere NT-proBNP for Alinity i Reagent ABBOTT ARCHITECT Anti-CCP Axis-Shield Anti-CCP AXIS-SHIELD ANTI-CCP Carolina Liquid Chemistries Sekisui Diagnostics Gold Standard Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device