BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Tissue-Tek® anti-Cytomegalovirus Antibody Cocktail [DDG9/CCH2]

    Reg #: 2083544 · FEI: 2083544 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    64
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SAKURA FINETEK U.S.A., INC.
    Registration Number
    2083544
    FEI Number
    2083544
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1750 W 214th St
    City
    TORRANCE
    State
    CA
    ZIP
    90501
    Country
    US

    Owner / Operator

    Firm Name
    Sakura Global Holding Company
    Operator Number
    8031662
    Address
    1750 W 214th St
    City
    Torrance
    State
    CA
    Postal Code
    90501
    Country
    US

    Products

    Device Name Product Code
    Reagents, Specific, Analyte MVU

    Proprietary Names

    Tissue-Tek® anti-Cytomegalovirus Antibody Cocktail [DDG9/CCH2] Tissue-Tek® anti-Procollagen-1 Rat Monoclonal Antibody [M-58] Tissue-Tek® anti-Herpes Simplex Virus 1 Rabbit Polyclonal Antibody Tissue-Tek® anti-Treponema pallidum Rabbit Polyclonal Antibody Genemed TERC Red and Chromosome 3 Centromere Green FISH Probe Cocktail, Ready-To-Use, 100 uL Tissue-Tek® anti-p16 Mouse Monoclonal Antibody [MX007] Genemed HER2 Red and Chromosome 17 Centromere Green FISH Probe Cocktail, 100 uL Genemed Rabbit Monoclonal anti-EGFR Antibody. Clone GR018, Concentrate, 1 mL Genemed Mouse anti-ER, Clone GM029, Concentrate, 1 mL Genemed EGFR Green and Chromosome 7 Centromere Red FISH Probe, Ready-To-Use, 100 uL Genemed Rabbit anti-ER, Clone EP1, Concentrate, 0.5 mL Genemed Mouse anti-ER, Clone GM029, Concentrate, 0.2 mL Genemed Rabbit anti-HER2 (c-erbB-2), Clone GR011, Concentrate, 0.2 mL Genemed Rabbit anti-HER2 (c-erbB-2), Clone GR011, Concentrate, 1 mL Genemed Chromosome X Centromere Probe, DIG-Labeled, Ready-To-Use, 400 uL Genemed Rabbit anti-ER, Clone EP1, Concentrate, 0.2 mL Genemed Rabbit Monoclonal Anti-Estrogen Receptor (ER) alpha positive cells, Clone GR001, Concentrate, 0.5 mL Genemed Rabbit Monoclonal anti-Progesterone Receptor (PR), Clone Y85, Ready-To-Use, 7 mL Tissue-Tek® anti-Herpes Simplex Virus 2 Rabbit Polyclonal Antibody Genemed Chromosome 3 Centromere, DIG-Labeled Probe, Ready-To-Use, 400 uL Genemed Rabbit anti-HER-2 (c-erbB-2), Clone GR011, Ready-To-Use, 7 mL Tissue-Tek® anti-Estrogen Receptor ? Rabbit Monoclonal Antibody [EP1] Genemed Rabbit Monoclonal anti-Progesterone Receptor (PR), Clone Y85, Concentrate, 1 mL Genemed HER2 CISH DIG-Labeled Probe, Ready-To-Use, 400 uL Genemed Chromosome 7 Centromere, DIG-Labeled Probe, Ready-To-Use, 400 uL Genemed Rabbit Monoclonal anti-EGFR Antibody. Clone GR018, Concentrate, 0.5 mL Genemed Rabbit Monoclonal Anti-Estrogen Receptor (ER) alpha positive cells, Clone GR001, Concentrate, 0.2 mL Genemed Mouse anti-ER, Clone 1D5, Ready-To-Use, 7 mL Genemed Rabbit Monoclonal anti-EGFR Antibody. Clone GR018, Concentrate, 0.2 mL Genemed EBER, DIG-Labeled Probe, Ready-To-Use, 400 uL Genemed Rabbit anti-HER2 (c-erbB-2), Clone GR011, Concentrate, 0.5 mL Tissue-Tek® anti-Progesterone Receptor Rabbit Monoclonal Antibody [Y85] Genemed Rabbit anti-ER, Clone EP1, Ready-To-Use, 7 mL Genemed® anti-p16 Mouse Monoclonal Antibody [MX007], RTU, 15 mL Genemed Rabbit Monoclonal anti-Progesterone Receptor (PR), Clone Y85, Concentrate, 0.5 mL Genemed Rabbit anti-ER, Clone EP1, Concentrate, 1 mL Tissue-Tek® anti-HER2 Rabbit Monoclonal Antibody [GR011] Genemed Rabbit Monoclonal anti-Progesterone Receptor (PR), Clone Y85, Concentrate, 0.2 mL Genemed Rabbit Monoclonal anti-EGFR Antibody. Clone GR018, Ready-To-Use, 7 mL Genemed Rabbit Monoclonal Anti-Estrogen Receptor (ER) alpha positive cells. Clone GR001, Ready-to-use, 7 mL Genemed Mouse anti-ER, Clone GM029, Concentrate, 0.5 mL Genemed HER2 Green and Chromosome 17 Centromere Red FISH Probe Cocktail, Ready-To-Use, 100 uL Genemed Rabbit Monoclonal Anti-Estrogen Receptor (ER) alpha positive cells, Clone GR001, Concentrate, 1 mL Genemed® anti-Treponema Pallidum Rabbit Polyclonal Antibody, RTU, 15 mL Genemed Chromosome 17 Centromere Probe, DIG-Labeled, Ready-To-Use, 400 uL Genemed® anti-ALK (Lung) Mouse Monoclonal Antibody [1A4] Genemed® anti-Cytomegalovirus (CMV) Mouse Monoclonal Antibody [DDG9/CCH2], RTU, 15 mL Genemed® anti-Herpes Simplex Virus 1 (HSV1) Rabbit Polyclonal Antibody, RTU, 15 mL Genemed® anti-Herpes Simplex Virus 2 (HSV2) Rabbit Polyclonal Antibody, RTU, 15 mL Genemed® anti-Estrogen Receptor ? Rabbit Monoclonal Antibody [EP1], RTU, 15 mL Genemed® anti-Progesterone Receptor Rabbit Monoclonal Antibody [Y85], RTU, 15 mL Genemed® anti-Procollagen I Rat Monoclonal Antibody [M-58], RTU, 15 mL Genemed® anti-HER2 Rabbit Monoclonal Antibody [GR011], RTU, 15 mL Genemed® CISH Amplification Linker Ready-To-Use Genemed® ISH Kappa Probe RTU, 1 bottle, 15 mL Genemed® CISH Negative Control Ready-To-Use Genemed® anti-PD-L1 Rabbit Monoclonal Antibody [RM320] Ready-To-Use, 15 mL Genemed® CISH Positive Control Ready-To-Use Genemed® CISH EBER Probe RTU, 1 bottle, 15 mL Genemed CISH Lambda Probe Ready-To-Use Genemed® anti-HER2 Rabbit Monoclonal Antibody [EP3]; RTU, 15 mL Genemed® CISH Kappa Probe, 30 tests Genemed® CISH mRNA Negative Control, 30 tests Genemed® CISH mRNA Positive Control ,30 tests

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device