BEUDAMED
    FDA Registration Active 🇺🇸 United States

    goldFISH DF068 MDM2/CSP12 Dual Color Probe

    Reg #: 3010139432 · FEI: 3010139432 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    40
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    LUMATAS BIOSYSTEMS, INC
    Registration Number
    3010139432
    FEI Number
    3010139432
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1870 Milmont Drive
    City
    Milpitas
    State
    CA
    ZIP
    95035
    Country
    US

    Owner / Operator

    Firm Name
    Lumatas BioSystems, Inc
    Operator Number
    10043710
    Address
    1870 Milmont Drive
    City
    Milpitas
    State
    CA
    Postal Code
    95035
    Country
    US
    Correspondent
    Delia Yuen

    Products

    Device Name Product Code
    Reagents, Specific, Analyte MVU

    Proprietary Names

    goldFISH DF068 MDM2/CSP12 Dual Color Probe goldFISH DF027 IRF4 Dual Color Break Apart Probe goldFISH DF209 MYEOV/IGH Dual Color Dual Fusion Probe goldFISH DF206 MAF/IGH Dual Color Dual Fusion Probe goldFISH DF207 MAFB/IGH Dual Color Dual Fusion Probe goldFISH DF156 CTNNB1/CSP3 Dual Color Probe goldFISH DF073 MYB Dual Color Break Apart Probe goldFISH DF208 FGFR3/IGH Dual Color Dual Fusion Probe goldFISH DF005 ALK Dual Color Break Apart Probe goldFISH DF047 PML/RARA Dual Color Dual Fusion Probe goldFISH DF081 COL1A1/PDGFB Dual Color Dual Fusion Probe goldFISH DF091 SS18 Dual Color Break Apart Probe goldFISH DF015 BCL2 Dual Color Break Apart Probe goldFISH DF129 EWSR1/FLI1 Dual Color Dual Fusion Probe goldFISH DF044 MYCN/CSP2 Dual Color Probe goldFISH DF101 ROS1 Dual Color Break Apart Probe goldFISH DF035 CCND1/IGH Dual Color Dual Fusion Probe goldFISH DF282 MYB/CSP6 Dual Color Probe goldFISH DF040 PPARG/CSP3 Dual Color Probe goldFISH DF094 FGFR2 Dual Color Break Apart Probe goldFISH DF480 D20S108/20q13 Dual Color Probe goldFISH DF008 MYC Dual Color Break Apart Probe goldFISH DF067 CDKN2A/CSP9 Dual Color Probe goldFISH DF006 MET/CSP7 Dual Color Probe goldFISH DF059 D7S486/CSP7 Dual Color Probe goldFISH DF001 HER2/CSP17 Dual Color Probe goldFISH DF046 BCR/ABL Dual Color Dual Fusion Probe goldFISH DF016 BCL6 Dual Color Break Apart Probe goldFISH DF037 IGH Dual Color Break Apart Probe goldFISH DF458 TP73/ABL2 Dual Color Probe goldFISH DF036 BCL2/IGH Dual Color Dual Fusion Probe goldFISH DF330 CHOP Dual Color Break Apart Probe goldFISH DF069 p53/CSP17 Dual Color Probe goldFISH DF088 EGR1/TERT Dual Color Probe goldFISH DF045 AML1/ETO Dual Color Dual Fusion Probe goldFISH DF103 EGFR/CSP7 Dual Color Probe goldFISH DF043 EWSR1 Dual Color Break Apart Probe goldFISH DF100 PAX3 Dual Color Break Apart Probe goldFISH DF514 CDKN2C/CKS1B Dual Color Probe goldFISH DF204 ATM/CSP11 Dual Color Probe

    Establishment Types

    Repack or Relabel Medical Device