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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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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
Adenovirus Low Run Control
EXACT DIAGNOSTICS, LLC
ADVL101
In Commercial Distribution

  • 00812242030321 ()
ADVL101

  • Adenovirus nucleic acid IVD, control
Adenovirus Verification Panel
EXACT DIAGNOSTICS, LLC
ADVP100
In Commercial Distribution

  • 00812242030314 ()
ADVP100

  • Adenovirus nucleic acid IVD, calibrator
HBV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HBVAMR
In Commercial Distribution

  • 00812242030222 ()
HBVAMR

  • Hepatitis B virus nucleic acid IVD, calibrator
HCV Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HCVAMR
In Commercial Distribution

  • 00812242030215 ()
HCVAMR

  • Hepatitis C virus nucleic acid IVD, calibrator
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