Manufacturer's Devices - Beckman Coulter Inc.

Address:




250 South Kraemer Boulevard



Brea

California -

United States

Serilization:


Authorised Representative
Name: Beckman Coulter UK Ltd
Address:

Oakley Court Kingsmead Busines sPark

London Rd

High Wycombe

Bucks HP11 1JU

United Kingdom




Code/Term Type
Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassayIVD Annex II List A
Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassayIVD Annex II List A
Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassayIVD Annex II List A
Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassayIVD Annex II List A
Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayIVD Annex II List B
Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassayIVD Annex II List B
Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)IVD Annex II List B
Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayIVD Annex II List B
Trisomy 21-risk hormone IVD, kit, chemiluminescent immunoassayIVD Annex II List B
Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassayIVD Annex II List B
Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassayIVD Annex II List B
Nephelometry/turbidimetry analyser IVD, manualIVD General
Multiple lipid analyte IVD, controlIVD General
Lipoprotein A IVD, calibratorIVD General
Multiple-type clinical chemistry analyte profile IVD, calibratorIVD General
Beta-haemolytic Group A Streptococcus DNAse B antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Lipoprotein A IVD, reagentIVD General
Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetryIVD General
Apolipoprotein B (Apo B) IVD, kit, nephelometry/turbidimetryIVD General
Multiple clinical chemistry protein IVD, controlIVD General
Alpha-1-antitrypsin (protease inhibitor) IVD, kit, nephelometry/turbidimetryIVD General
Alpha-1-acid glycoprotein (orosomucoid) IVD, kit, nephelometry/turbidimetryIVD General
Ceruloplasmin IVD, kit, nephelometry/turbidimetryIVD General
Complement components C3/C3c IVD, kit, nephelometry/turbidimetryIVD General
Complement components C4/C4c IVD, kit, nephelometry/turbidimetryIVD General
C-reactive protein (CRP) IVD, kit, nephelometry/turbidimetryIVD General
Ferritin IVD, kit, enzyme immunoassay (EIA)IVD General
Haptoglobin IVD, kit, nephelometry/turbidimetryIVD General
Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetryIVD General
Total immunoglobulin G (IgG total) IVD, kit, nephelometry/turbidimetryIVD General
Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetryIVD General
Kappa/lambda light chain immunoglobulin IVD, kit, nephelometry/turbidimetryIVD General
Alpha-1-microglobulin IVD, kit, nephelometry/turbidimetryIVD General
Alpha-2-macroglobulin IVD, kit, nephelometry/turbidimetryIVD General
Prealbumin (transthyretin) IVD, kit, nephelometry/turbidimetryIVD General
Rheumatoid factor IVD, kit, nephelometry/turbidimetryIVD General
Antithrombin III (ATIII) IVD, reagentIVD General
Total immunoglobulin E (IgE total) IVD, antibodyIVD General
Buffered sample diluent IVD, automated/semi-automated systemIVD General
Transferrin IVD, kit, nephelometry/turbidimetryIVD General
Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, kit, nephelometry/turbidimetryIVD General
Wash/cleaning solution IVD, automated/semi-automated systemIVD General
Albumin IVD, kit, spectrophotometryIVD General
Complement factor B IVD, reagentIVD General
Assay container IVD, single-useIVD General
Folate (vitamin B9) IVD, calibratorIVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD, calibratorIVD General
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassayIVD General
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibratorIVD General
B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, controlIVD General
General specimen container IVD, no additive/mediumIVD General
Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassayIVD General
Hepatitis A virus total antibody IVD, kit, chemiluminescent immunoassayIVD General
Bone alkaline phosphatase (BALP) IVD, kit, chemiluminescent immunoassayIVD General
Creatine kinase myocardial isoenzyme (CKMB) IVD, reagentIVD General
Interleukin-6 (IL-6) IVD, kit, chemiluminescent immunoassayIVD General
Myoglobin IVD, kit, chemiluminescent immunoassayIVD General
Soluble transferrin receptor IVD, calibratorIVD General
Soluble transferrin receptor IVD, controlIVD General
Soluble transferrin receptor IVD, reagentIVD General
Free cortisol IVD, kit, enzyme immunoassay (EIA)IVD General
C-peptide IVD, kit, chemiluminescent immunoassayIVD General
Erythropoietin (EPO) IVD, kit, chemiluminescent immunoassayIVD General
Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)IVD General
Free testosterone IVD, kit, enzyme immunoassay (EIA)IVD General
Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassayIVD General
Human growth hormone (HGH) IVD, kit, chemiluminescent immunoassayIVD General
Insulin IVD, kit, chemiluminescent immunoassayIVD General
Luteinizing hormone (LH) IVD, kit, chemiluminescent immunoassayIVD General
Parathyroid hormone (PTH) IVD, kit, chemiluminescent immunoassayIVD General
Progesterone IVD, kit, chemiluminescent immunoassayIVD General
Prolactin IVD, kit, chemiluminescent immunoassayIVD General
Sex hormone binding globulin (SHBG) IVD, kit, chemiluminescent immunoassayIVD General
Thyroglobulin IVD, kit, chemiluminescent immunoassayIVD General
Thyroid stimulating hormone (TSH) IVD, kit, chemiluminescent immunoassayIVD General
Thyroid uptake (T-uptake) IVD, kit, chemiluminescent immunoassayIVD General
Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassayIVD General
Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassayIVD General
Reverse triiodothyronine (reverse T3) IVD, kit, chemiluminescent immunoassayIVD General
25-Hydroxy vitamin D2 IVD, reagentIVD General
Folate (vitamin B9) IVD, reagentIVD General
Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)IVD General
Cancer antigen 19-9 (CA19-9) IVD, kit, enzyme immunoassay (EIA)IVD General
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassayIVD General
Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassayIVD General
Intrinsic factor/parietal cell antibody IVD, kit, enzyme immunoassay (EIA)IVD General
Thyroglobulin/Thyroid peroxidase antibody (anti-TPO/Microsomal antibody) IVD, kit, enzyme immunoassay (EIA)IVD General
Digoxin therapeutic drug monitoring IVD, kit, chemiluminescent assayIVD General
Multiple clinical chemistry analyser IVD, laboratory, automatedIVD General
Chemiluminescent immunoassay analyser IVD, automatedIVD General
Immunohistochemistry wash buffer reagent IVDIVD General
Optical instrument performance standard calibrator/control IVD, single-useIVD General
Chemiluminescent substrate reagent IVDIVD General
Thyroglobulin antibody IVD, kit, chemiluminescent immunoassayIVD General
Vitamin B12 IVD, kit, chemiluminescent immunoassayIVD General
Troponin I IVD, kit, chemiluminescent immunoassayIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassayIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassayIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, controlIVD General
SARS-CoV-2 immunoglobulin G (IgG) antibody IVD, calibratorIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, controlIVD General
SARS-CoV-2 immunoglobulin M (IgM) antibody IVD, calibratorIVD General
Acetylcholinesterase IVD, kit, enzyme spectrophotometryIVD General