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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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HCV High Run Control
EXACT DIAGNOSTICS, LLC
HCVH102
In Commercial Distribution

  • 00812242030109 ()
HCVH102

  • Hepatitis C virus nucleic acid IVD, control
HCV Low Run Control
EXACT DIAGNOSTICS, LLC
HCVL101
In Commercial Distribution

  • 00812242030093 ()
HCVL101

  • Hepatitis C virus nucleic acid IVD, control
HCV Verification Panel
EXACT DIAGNOSTICS, LLC
HCVP100
In Commercial Distribution

  • 00812242030086 ()
HCVP100

  • Hepatitis C virus nucleic acid IVD, calibrator
Bulk Negative
EXACT DIAGNOSTICS, LLC
NEG050
In Commercial Distribution

  • 00812242030079 ()
NEG050

  • PCR/NAT negative control IVD
Negative Run Control
EXACT DIAGNOSTICS, LLC
NEG000
In Commercial Distribution

  • 00812242030062 ()
NEG000

  • PCR/NAT negative control IVD
CMV High Run Control
EXACT DIAGNOSTICS, LLC
CMVH102
In Commercial Distribution

  • 00812242030055 ()
CMVH102

  • Cytomegalovirus (CMV) nucleic acid IVD, control
CMV Low Run Control
EXACT DIAGNOSTICS, LLC
CMVL101
In Commercial Distribution

  • 00812242030048 ()
CMVL101

  • Cytomegalovirus (CMV) nucleic acid IVD, control
CMV Verification Panel
EXACT DIAGNOSTICS, LLC
CMVP100
In Commercial Distribution

  • 00812242030031 ()
CMVP100

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
HIV-1 High Run Control
EXACT DIAGNOSTICS, LLC
HIVH102
In Commercial Distribution

  • 00812242030024 ()
HIVH102

  • HIV1 nucleic acid IVD, control
HIV-1 Low Run Control
EXACT DIAGNOSTICS, LLC
HIVL101
In Commercial Distribution

  • 00812242030017 ()
HIVL101

  • HIV1 nucleic acid IVD, control
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