BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Dimension(r) Reaction Vessels

    Reg #: 3007135420 · FEI: 3007135420 · Expires 2025
    View on FDA
    Products
    58
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    58

    Registration Details

    Registration Name
    Carclo Technical Plastics - Latrobe
    Registration Number
    3007135420
    FEI Number
    3007135420
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    600 Depot St
    City
    Latrobe
    State
    PA
    ZIP
    15650
    Country
    US

    Regulatory Submissions

    510(k) Number
    K022603

    Owner / Operator

    Firm Name
    CARCLO TECHNICAL PLASTICS
    Operator Number
    9020456
    Address
    600 DEPOT ST., --
    City
    Latrobe
    State
    PA
    Postal Code
    15650
    Country
    US
    Correspondent
    Brian Kochanski

    Products

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

    Proprietary Names

    Dimension(r) Reaction Vessels

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)