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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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Parvovirus B19 Verification Panel
EXACT DIAGNOSTICS, LLC
B19P100
In Commercial Distribution

  • 00812242030475 ()
B19P100

  • Parvovirus B19 nucleic acid IVD, calibrator
HSV-2 High Run Control
EXACT DIAGNOSTICS, LLC
HSV2H102
In Commercial Distribution

  • 00812242030468 ()
HSV2H102

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
HSV-2 Low Run Control
EXACT DIAGNOSTICS, LLC
HSV2L101
In Commercial Distribution

  • 00812242030451 ()
HSV2L101

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
HSV-2 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV2P100
In Commercial Distribution

  • 00812242030444 ()
HSV2P100

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator
HSV-1 High Run Control
EXACT DIAGNOSTICS, LLC
HSV1H102
In Commercial Distribution

  • 00812242030437 ()
HSV1H102

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
HSV-1 Low Run Control
EXACT DIAGNOSTICS, LLC
HSV1L101
In Commercial Distribution

  • 00812242030420 ()
HSV1L101

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
HSV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV1P100
In Commercial Distribution

  • 00812242030413 ()
HSV1P100

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator
HHV-6 High Run Control
EXACT DIAGNOSTICS, LLC
HV6H102
In Commercial Distribution

  • 00812242030406 ()
HV6H102

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, control
HHV-6 Low Run Control
EXACT DIAGNOSTICS, LLC
HV6L101
In Commercial Distribution

  • 00812242030390 ()
HV6L101

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, control
HHV-6B Verification Panel
EXACT DIAGNOSTICS, LLC
HV6BP100
In Commercial Distribution

  • 00812242030383 ()
HV6BP100

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, calibrator
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