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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 Verification Panel
EXACT DIAGNOSTICS, LLC
HSVP200
In Commercial Distribution

  • 00812242030710 ()
HSVP200

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
HBV 1E6 IU/mL Precision
EXACT DIAGNOSTICS, LLC
HBVH202
In Commercial Distribution

  • 00812242030697 ()
HBVH202

  • Hepatitis B virus nucleic acid IVD, calibrator
HBV 1E3 IU/mL Precision
EXACT DIAGNOSTICS, LLC
HBVL201
In Commercial Distribution

  • 00812242030680 ()
HBVL201

  • Hepatitis B virus nucleic acid IVD, calibrator
HCV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HCVP200
In Commercial Distribution

  • 00812242030635 ()
HCVP200

  • Hepatitis C virus nucleic acid IVD, calibrator
CMV 5E5 IU/mL Precision
EXACT DIAGNOSTICS, LLC
CMVH202
In Commercial Distribution

  • 00812242030611 ()
CMVH202

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
CMV 1E3 IU/mL Precision
EXACT DIAGNOSTICS, LLC
CMVL201
In Commercial Distribution

  • 00812242030604 ()
CMVL201

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
CMV Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
CMVP200
In Commercial Distribution

  • 00812242030598 ()
CMVP200

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator
HIV-1 1E5 cp/mL Precision
EXACT DIAGNOSTICS, LLC
HIVH202
In Commercial Distribution

  • 00812242030574 ()
HIVH202

  • HIV1 nucleic acid IVD, calibrator
HIV-1 1E3 cp/mL Precision
EXACT DIAGNOSTICS, LLC
HIVL201
In Commercial Distribution

  • 00812242030567 ()
HIVL201

  • HIV1 nucleic acid IVD, calibrator
HIV-1 Verification Panel 1.4mL
EXACT DIAGNOSTICS, LLC
HIVP200
In Commercial Distribution

  • 00812242030550 ()
HIVP200

  • HIV1 nucleic acid IVD, calibrator
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