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    FDA Registration Active 🇺🇸 United States

    Exact Diagnostics CMV Verification Panel [CMVP100]

    Reg #: 3011926203 · FEI: 3011926203 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    34
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    EXACT DIAGNOSTICS
    Registration Number
    3011926203
    FEI Number
    3011926203
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    100 South Jones Street Suite #100
    City
    Fort Worth
    State
    TX
    ZIP
    76104
    Country
    US

    Owner / Operator

    Firm Name
    Bio-Rad Laboratories, Inc.
    Operator Number
    9929003
    Address
    4000 Alfred Nobel Drive, --
    City
    Hercules
    State
    CA
    Postal Code
    94547
    Country
    US
    Correspondent
    Elizabeth Platt

    Products

    Device Name Product Code
    Calibrator, Secondary JIT

    Proprietary Names

    Exact Diagnostics CMV Verification Panel [CMVP100] Exact Diagnostics HCV Verification Panel 1.4 mL [HCVP200] Exact Diagnostics Zika Verification Panel [ZKVP100] Exact Diagnostics BKV Verification Panel [BKVP100] Exact Diagnostics HCV LOD [HCVLOD] Exact Diagnostics HIV-1 Verification Panel [HIVP100] Exact Diagnostics HBV Verification Panel 1.4 mL [HBVP200] Exact Diagnostics HIV-1 1E5 cp/mL Precision [HIVH202] Exact Diagnostics HCV 1E6 IU/mL Precision [HCVH202] Exact Diagnostics HSV-2 Verification Panel [HSV2P100] Exact Diagnostics C. difficile Verification Panel [CDFP200] Exact Diagnostics HCV Verification Panel [HCVP100] Exact Diagnositics Adenovirus Verification Panel [ADVP100] Exact Diagnostics CMV 5E5 IU/mL Precision [CMVH201] Exact Diagnostics HIV-1 LOD [HIVLOD] Exact Diagnostics HIV-1 Verification Panel 1.4 mL [HIVP200] Exact Diagnostics HSV-1 Verification Panel [HSV1P100] Exact Diagnostics JCV Verification Panel [JCVP100] Exact Diagnostics HIV-1 1E3 cp/mL Precision [HIVL201] Exact Diagnostics HHV-6B Verification Panel [HV6BP100] Exact Diagnostics EBV Verification Panel [EBVP100] Exact Diagnostics CMV Verification Panel 1.4 mL [CMVP200] Exact Diagnostics Parvovirus B19 Verification Panel [B19P100] Exact Diagnostics HBV 1E3 IU/mL Precision [HBVL201] Exact Diagnostics HBV LOD [HBVLOD] Exact Diagnostics HBV Verification Panel [HBVP100] Exact Diagnostics VZV Verification Panel [VZVP100] Exact Diagnostics CT/NG Verification Panel [CTNGP200] Exact Diagnostics CMV 1E3 IU/mL Precision [CMVL201] Exact Diagnostics HCV 1E3 IU/mL Precision [HCVL201] Exact Diagnostics TV/MG Verification Panel [TVMGP200] Exact Diagnostics CMV LOD [CMVLOD] Exact Diagnostics HBV 1E6 IU/mL Precision [HBVH202] Exact Diagnostics HHV-6A Verification Panel [HV6AP100]

    Establishment Types

    Manufacture Medical Device