BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Copy Control 6q11.1 Aqua

    Reg #: 3004140393 · FEI: 3004140393 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    67
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOCARE MEDICAL, LLC
    Registration Number
    3004140393
    FEI Number
    3004140393
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    60 Berry Drive
    City
    Pacheco
    State
    CA
    ZIP
    94553
    Country
    US

    Owner / Operator

    Firm Name
    BIOCARE HOLDINGS, LLC
    Operator Number
    9058052
    Address
    3033 E. 1st Avenue, Suite 700, --
    City
    Denver
    State
    CO
    Postal Code
    80206
    Country
    US

    Products

    Device Name Product Code
    Reagents, Specific, Analyte MVU

    Proprietary Names

    Copy Control 6q11.1 Aqua Helicobacter pylori Copy Control 12 Green Copy Control 7 Orange HPV Type 6 Probe (Digoxigenin) RISH™ Epstein-Barr Encoded RNA (EBER) Probe FGFR3 (4p16.3) Aqua LAMP1 (13q34) Aqua Epstein-Barr Virus (EBV) HPV Type 16 Probe (Digoxigenin) CCND1 (11q13) Orange TERC (3q26.2) Red Copy Control 15 Orange Cytomegalovirus (CMV) D13S319 (13q14.2) Orange 1p21.2 Green FGFR3 (4p16.3) Orange LAMP1 (13q34) Green 1q21.3 Orange MYB (6q23) Orange ATM (11q22.3) Aqua Copy Control 3 Aqua Copy Control 4q12 Green 5p15.2 Green P504S (P) AMACR (RM) COPY CONTROL 18 Aqua c-erbB-2/HER2 HPV Type 51 Probe (Digoxigenin) RISHTM Cytomegalovirus (CMV) Probe CDKN2A (9p21.3) Orange TP53 (17p13) Orange ATM (11q22.3) Orange RISH™ Lambda Light Chain DNA Probe 20q13.2 Aqua MYC (8q24) Green ERBB2 (17q12) Red IGH (14q32) Green Estrogen Receptor (ER) [SP1] IGH (14q32) Variable Green 6q21 Green COPY CONTROL 17 Green RB1 (13q14.2) Green 5p15.2 Red P504S-2X Copy Control 12 Aqua Copy Control 7 Green Copy Control 17 Aqua D13S25 (13q14.3) Orange Copy Control 4q12 Aqua AMACR (RM), 2X COPY CONTROL 1p12 Green Copy Control 6q11.1 Green HER2/neu [IHC042] ATM (11q22.3) Green IGH (14q32) Constant Orange RISH™ Kappa Light Chain DNA Probe Copy Control 10 Green 20q13.2 Orange P504S (AMACR) (RM) [13H4] HPV Type 18 Probe (Digoxigenin) Copy Control 7 Aqua HHV-8 [13B10] HPV Type 31 Probe (Digoxigenin) RB1 (13q14.2) Orange Copy Control 7 Gold HPV Type 11 Probe (Digoxigenin)

    Establishment Types

    Manufacture Medical Device