BEUDAMED
    FDA Registration Active 🇺🇸 United States

    VIROCLEAR MuMZ

    Reg #: 3011926203 · FEI: 3011926203 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    130
    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
    Multi-Analyte Controls Unassayed OHQ

    Proprietary Names

    VIROCLEAR MuMZ VIROTROL Syphilis LR-A PyloriTrol VIROTROL EBV Liquichek Sedimentation Rate Control VIROTROL WNV VIROTROL MuMZ VIROTROL HIV-1 gO Amplichek STI VIROCLEAR EBV VIROTROL Chagas VIROTROL Lyme Liquichek Netherlands Unassayed Chemistry Plus Control Liquid Unassayed Multiqual VIROTROL HAV-IgM VIROTROL HBeAg VIROTROL RPR Panel VIROCLEAR ToRCH Lyphochek Unassayed Chemistry VIROTROL PLUS R Liquichek Unassayed Chemistry VIROTROL ToRCH-M [00117A, 00117B] VIROCLEAR SARS-CoV-2 EDX SARS-CoV-2 Positive Run Control [COV019CE] BKV 5E5 IU/mL Precision [BKVH202] EDX VZV Verification Panel [VZVP100] EDX EBV High Run Control [EBVH102] EDX HHV-6 High Run Control [HV6H102] HIV-1 1E3 cp/mL Precision [HIVL201] EDX Bulk Negative [NEG050] EDX CMV High Run Control [CMVH102] EDX HPV Genotype 18 Control [HPV18C] EDX HPV Genotype 68 Control [HPV68C] EDX Bartonella Run Control [BRTRC] EDX JCV Low Run Control [JCVL101] EDX SARS-CoV-2, Flu, RSV Negative Run Control [COVFLUNEG] HIV-1 1E5 cp/mL Precision [HIVH202] BKV Verification Panel 1.4 IU/mL [BKVP200] EDX HSV-1 High Run Control [HSV1H102] EBV 5E5 IU/mL Precision [EBVH202] EDX HBV Low Run Control [HBVL101] EDX HBV High Run Control [HBVH102] EDX Adenovirus Verification Panel [ADVP100] EDX CMV Low Run Control [CMVL101] EDX HSV-2 High Run Control [HSV2H102] BKV 1E3 IU/mL Precision [BKVL201] EDX JCV High Run Control [JCVH102] HBV 1E6 IU/mL Precision [HBVH202] EDX HSV-2 Low Run Control [HSV2L101] EDX C. difficile Verification Bundle [CDFP200] EDX HBV Analytical Measurement Range Panel [HBVAMR] EDX Respiratory Run Control [RPRC] VIROTROL SARS-CoV-2 EDX JCV Verification Panel [JCVP100] EDX HIV-1 Verification Panel 1mL [HIVP100] EDX HHV-6A Verification Panel [HV6AP100] EDX HIV-1 Analytical Measurement Range Panel [HIVAMR] EDX Parvovirus B19 Verification Panel [B19P100] EDX MRSA Verification Bundle [MRSAP200] EDX HCV High Run Control [HCVH102] EDX ZKV Verification Panel [ZKVP100] EDX BKV Urine LOD [BKVULOD] EDX HCV Low Run Control [HCVL101] EDX Adenovirus High Run Control [ADVH102] EDX VZV Low Run Control [VZVL101] EDX HHV-6B Verification Panel [HV6BP100] EDX Adenovirus Low Run Control [ADVL101] EDX CT/NG Verification Bundle [CTNGP200] EDX HSV-2 Verification Panel [HSV2P100] HCV LOD [ HCVLOD] EDX BKV High Run Control [BKVH102] EDX HCV Verification Panel 1mL [HCVP100] EBV 1E3 IU/mL Precision [EBVL201] EDX HIV-1 Verification Panel 1.4mL [HIVP200] EDX HCV Analytical Measurement Range Panel [HCVAMR] EDX SARS-CoV-2 Negative Run Control [COV000CE] EDX Negative Run Control [NEG000] EBV Verification Panel 1.4 IU/mL [EBVP200] EDX HIV-1 High Run Control [HIVH102] EDX Parvovirus B19 Low Run Control [B19L101] HBV LOD [HBVLOD] EDX CMV Verification Panel 1mL [CMVP100] EDX Parvovirus B19 High Run Control [B19H102] HBV 1E3 IU/mL Precision [HBVL201] EDX HSV-1 Low Run Control [HSV1L101] EDX HPV Genotype 16 Control [HPV16C] EDX Anaplasma Run Control [ANARC] EDX Respiratory Negative Run Control [RPNEG] CMV 1E3 IU/mL Precision [CMVL201] HCV 1E6 IU/mL Precision [HCVH202] EDX ZKV Low Run Control [ZKVL101] HIV-1 LOD [HIVLOD] EBV LOD [EBVLOD] EDX Synthetic Negative Run Control [NEGSYN] EDX HCV Verification Panel 1.4mL [HCVP200] EDX HSV-1 Verification Panel [HSV1P100] EDX Enterovirus Run Control [EVRC] EDX Borrelia Run Control [BORRC] EDX Respiratory Positive Run Control [RPPOS] HCV 1E3 IU/mL Precision [HCVL201] EDX HHV-6 Low Run Control [HV6L101] EDX EBV Low Run Control [EBVL101] EDX HBV Verification Panel 1mL [HBVP100] EDX EBV Verification Panel [EBVP100] EDX HPV Negative Control [HPVNEG] EDX ZKV High Run Control [ZKVH102] CMV 5E5 IU/mL Precision [CMVH202] EDX TV/MG Verification Bundle [TVMGP200] EDX VZV High Run Control [VZVH102] EDX Babesia Run Control [BABRC] EDX HIV-1 Low Run Control [HIVL101] EDX HBV Verification Panel 1.4mL [HBVP200] BKV LOD [BKVLOD] EDX CMV Verification Panel 1.4mL [CMVP200] CMV LOD [CMVLOD] EDX Ehrlichia Run Control [ERLRC] EDX CT/NG Run Control [CTNGRC] EDX SARS-CoV-2, Flu, RSV Positive Run Control [COVFLU] EDX BKV Low Run Control [BKVL101] EDX HAI Run Control [NEGHAI] EDX HPV Verification Panel [HPVP200] EDX BKV Verification Panel [BKVP100] EDX CT/NG Positive Run Control [CTNGPOS] EDX GBS Positive Run Control [12020069] EDX Bulk CSF Negative [12019432] EDX GBS Negative Run Control [12020068] EDX STI Negative Run Control [NEGSTI] Liquichek ToRCH Plus Control, Negative VIROTROL HBc-IgM Liquichek ToRCH Plus Control, Positive Unassayed

    Establishment Types

    Manufacture Medical Device