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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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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
HHV-6A Verification Panel
EXACT DIAGNOSTICS, LLC
HV6AP100
In Commercial Distribution

  • 00812242030376 ()
HV6AP100

  • Human herpesvirus 6 (HHV6) nucleic acid IVD, calibrator
VZV High Run Control
EXACT DIAGNOSTICS, LLC
VZVH102
In Commercial Distribution

  • 00812242030369 ()
VZVH102

  • Varicella-zoster virus (VZV) nucleic acid IVD, control
VZV Low Run Control
EXACT DIAGNOSTICS, LLC
VZVL101
In Commercial Distribution

  • 00812242030352 ()
VZVL101

  • Varicella-zoster virus (VZV) nucleic acid IVD, control
VZV Verification Panel
EXACT DIAGNOSTICS, LLC
VZVP100
In Commercial Distribution

  • 00812242030345 ()
VZVP100

  • Varicella-zoster virus (VZV) nucleic acid IVD, calibrator
Adenovirus High Run Control
EXACT DIAGNOSTICS, LLC
ADVH102
In Commercial Distribution

  • 00812242030338 ()
ADVH102

  • Adenovirus nucleic acid IVD, control
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