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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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HIV-1 Analytical Measurement Range Panel
EXACT DIAGNOSTICS, LLC
HIVAMR
In Commercial Distribution

  • 00812242030208 ()
HIVAMR

  • HIV1 nucleic acid IVD, calibrator
BKV High Run Control
EXACT DIAGNOSTICS, LLC
BKVH102
In Commercial Distribution

  • 00812242030192 ()
BKVH102

  • BK virus (BKV) nucleic acid IVD, control
BKV Low Run Control
EXACT DIAGNOSTICS, LLC
BKVL101
In Commercial Distribution

  • 00812242030185 ()
BKVL101

  • BK virus (BKV) nucleic acid IVD, control
BKV Verification Panel
EXACT DIAGNOSTICS, LLC
BKVP100
In Commercial Distribution

  • 00812242030178 ()
BKVP100

  • BK virus (BKV) nucleic acid IVD, calibrator
EBV High Run Control
EXACT DIAGNOSTICS, LLC
EBVH102
In Commercial Distribution

  • 00812242030161 ()
EBVH102

  • Epstein-Barr virus (EBV) nucleic acid IVD, control
EBV Low Run Control
EXACT DIAGNOSTICS, LLC
EBVL101
In Commercial Distribution

  • 00812242030154 ()
EBVL101

  • Epstein-Barr virus (EBV) nucleic acid IVD, control
EBV Verification Panel
EXACT DIAGNOSTICS, LLC
EBVP100
In Commercial Distribution

  • 00812242030147 ()
EBVP100

  • Epstein-Barr virus (EBV) nucleic acid IVD, calibrator
HBV High Run Control
EXACT DIAGNOSTICS, LLC
HBVH102
In Commercial Distribution

  • 00812242030130 ()
HBVH102

  • Hepatitis B virus nucleic acid IVD, control
HBV Low Run Control
EXACT DIAGNOSTICS, LLC
HBVL101
In Commercial Distribution

  • 00812242030123 ()
HBVL101

  • Hepatitis B virus nucleic acid IVD, control
HBV Verification Panel
EXACT DIAGNOSTICS, LLC
HBVP100
In Commercial Distribution

  • 00812242030116 ()
HBVP100

  • Hepatitis B virus nucleic acid IVD, calibrator
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