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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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SARS-CoV-2, Flu, RSV Positive Run Control
EXACT DIAGNOSTICS, LLC
COVFLU
In Commercial Distribution

  • 00812242030901 ()
COVFLU

  • Multiple-genus respiratory virus nucleic acid IVD, control
SARS-CoV-2 Negative Run Control
EXACT DIAGNOSTICS, LLC
COV000CE
In Commercial Distribution

  • 00812242030895 ()
COV000CE

  • SARS-CoV-2 nucleic acid IVD, control
SARS-CoV-2 Positive Run Control
EXACT DIAGNOSTICS, LLC
COV019CE
In Commercial Distribution

  • 00812242030888 ()
COV019CE

  • SARS-CoV-2 nucleic acid IVD, control
RP Negative Run Control
EXACT DIAGNOSTICS, LLC
RPNEG
In Commercial Distribution

  • 00812242030857 ()
RPNEG

  • Multiple-genus respiratory virus nucleic acid IVD, control
RP Positive Run Control
EXACT DIAGNOSTICS, LLC
RPPOS
In Commercial Distribution

  • 00812242030840 ()
RPPOS

  • Multiple-genus respiratory virus nucleic acid IVD, control
Ehrlichia Run Control
EXACT DIAGNOSTICS, LLC
ERLRC
In Commercial Distribution

  • 00812242030802 ()
ERLRC

  • Ehrlichia chaffeensis nucleic acid IVD, control
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
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