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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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Respiratory Run Control
EXACT DIAGNOSTICS, LLC
RPRC
Not in Commercial Distribution

  • 00812242030758 ()
RPRC

  • Multiple-genus respiratory virus nucleic acid IVD, control
CT/NG Verification Panel
EXACT DIAGNOSTICS, LLC
CTNGP200
In Commercial Distribution

  • 00812242030741 ()
CTNGP200

  • Multiple-type sexually transmitted pathogen nucleic acid IVD, control
C. difficile Verification Panel
EXACT DIAGNOSTICS, LLC
CDFP200
In Commercial Distribution

  • 00812242030734 ()
CDFP200

  • Clostridium difficile nucleic acid IVD, control
MRSA Verification Panel
EXACT DIAGNOSTICS, LLC
MRSAP200
In Commercial Distribution

  • 00812242030727 ()
MRSAP200

  • MRSA/MSSA nucleic acid IVD, control
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
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