BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IMMULITE Albumin

    Reg #: 2432235 · FEI: 2432235 · Expires 2025
    View on FDA
    Products
    59
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    59

    Registration Details

    Registration Name
    Siemens Healthcare Diagnostics Inc.
    Registration Number
    2432235
    FEI Number
    2432235
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    511 Benedict Ave
    City
    Tarrytown
    State
    NY
    ZIP
    10591
    Country
    US

    Regulatory Submissions

    510(k) Number
    K022603

    Owner / Operator

    Firm Name
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Operator Number
    9096044
    Address
    Siemens Healthcare Diagnostics Inc., 511 Benedict Avenue
    City
    Tarrytown
    State
    NY
    Postal Code
    10591
    Country
    US
    Correspondent
    Mary Seeger

    Products

    Device Name Product Code
    Radioimmunoassay, Estriol CGI
    System, Test, Beta-2-Microglobulin Immunological JZG
    Radioimmunoassay, Parathyroid Hormone CEW
    Fluorometric Method, Cpk Or Isoenzymes JHX
    Radioimmunoassay, Testosterones And Dihydrotestosterone CDZ
    System, Test, Thyroid Autoantibody JZO
    Acid Phosphatase (Prostatic), Tartrate Inhibited JFH
    Enzyme Immunoassay, Valproic Acid LEG
    Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii LGD
    Ige, Peroxidase, Antigen, Antiserum, Control DGO
    Urinary Homocystine (Nonquantitative) Test System LPS
    Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific LGC
    Acid, Folic, Radioimmunoassay CGN
    Radioimmunoassay, Free Thyroxine CEC
    System, Test, C-Reactive Protein DCN
    Enzyme Immunoassay, Digitoxin LFM
    Radioimmunoassay, Luteinizing Hormone CEP
    Column Chromatography & Color Development, Hydroxyproline JMM
    Immunoassay Method, Troponin Subunit MMI
    Enzyme Immunoassay, Digoxin KXT
    Radioimmunoassay, Cortisol CGR
    Enzyme Immunoassay, Carbamazepine KLT
    Radioimmunoassay, Estradiol CHP
    Radioimmunoassay, Human Placental Lactogen JMF
    Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine KLI
    Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers LTJ
    Enzyme Immunoassay, Amphetamine DKZ
    Helicobacter Pylori LYR
    Gas Chromatography, Methamphetamine LAF
    Radioimmunoassay, Human Growth Hormone CFL
    Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125) LTK
    Radioimmunoassay, Progesterone JLS
    System, Test, Radioallergosorbent (Rast) Immunological DHB
    Kit, Test,Alpha-Fetoprotein For Testicular Cancer LOJ
    Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus LFZ
    Radioimmunoassay, Cyclic Gmp CGT
    Radioimmunoassay, Immunoreactive Insulin CFP
    Radioimmunoassay, C-Peptides Of Proinsulin JKD
    Enzyme Immunoassay, Theophylline KLS
    Analyzer, Chemistry (Photometric, Discrete), For Clinical Use JJE
    Enzyme Immunoassay, Diphenylhydantoin DIP
    Enzyme Immunoassay, Cocaine And Cocaine Metabolites DIO
    Albumin, Rhodamine, Antigen, Antiserum, Control DFJ
    Radioimmunoassay, Prolactin (Lactogen) CFT
    System, Test, Thyroglobulin MSW
    System, Test, Human Chorionic Gonadotropin DHA
    Radioimmunoassay, Acth CKG
    System, Test, Immunological, Antigen, Tumor MOI
    Radioimmunoassay, Total Triiodothyronine CDP
    Radioimmunoassay, Thyroxine-Binding Globulin CEE
    System, Test, Carcinoembryonic Antigen DHX
    Radioimmunoassay (Two-Site Solid Phase), Ferritin JMG
    Enzyme Immunoassay, Cannabinoids LDJ
    Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) JKC
    Radioimmunoassay, Immunoglobulins (D, E) JHR
    Radioimmunoassay, Follicle-Stimulating Hormone CGJ
    Myoglobin, Antigen, Antiserum, Control DDR
    Radioassay, Vitamin B12 CDD
    Enzyme Linked Immunoabsorbent Assay, Rubella LFX

    Proprietary Names

    IMMULITE Albumin IMMULITE Insulin Insulin Control Module ACTH Control Module IML 2000 Albumin IMMULITE Albumin Sample Diluent Albumin Control Module IMMULITE 2000 Albumin IMMULITE/IMMULITE 1000 Albumin IMMULITE Albumin Control Module IMMULITE 1000 System IML 2000 Insulin IMMULITE/IMMULITE 1000 Chemiluminescent Substrate Module IMMULITE/IMMULITE 1000 Systems Sample Cups IMMULITE/IMMULITE 1000 Systems Sample Cup Caps

    Establishment Types

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