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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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Borrelia Run Control
EXACT DIAGNOSTICS, LLC
BORRC
In Commercial Distribution

  • 00812242030796 ()
BORRC

  • Borrelia burgdorferi nucleic acid IVD, control
Bartonella Run Control
EXACT DIAGNOSTICS, LLC
BRTRC
In Commercial Distribution

  • 00812242030789 ()
BRTRC

  • Bartonella quintana nucleic acid IVD, control
Babesia Run Control
EXACT DIAGNOSTICS, LLC
BABRC
In Commercial Distribution

  • 00812242030772 ()
BABRC

  • Babesia microti nucleic acid IVD, control
Anaplasma Run Control
EXACT DIAGNOSTICS, LLC
ANARC
In Commercial Distribution

  • 00812242030765 ()
ANARC

  • Anaplasma phagocytophilum nucleic acid IVD, control
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
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