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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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JCV Low Run Control
EXACT DIAGNOSTICS, LLC
JCVL101
In Commercial Distribution

  • 00812242030536 ()
JCVL101

  • JC virus (JCV) nucleic acid IVD, control
JCV Verification Panel
EXACT DIAGNOSTICS, LLC
JCVP100
In Commercial Distribution

  • 00812242030529 ()
JCVP100

  • JC virus (JCV) nucleic acid IVD, calibrator
Enterovirus Run Control
EXACT DIAGNOSTICS, LLC
EVRC
In Commercial Distribution

  • 00812242030505 ()
EVRC

  • Multiple-type meningitis-associated microorganism nucleic acid IVD, control
Parvovirus B19 High Run Control
EXACT DIAGNOSTICS, LLC
B19H102
In Commercial Distribution

  • 00812242030499 ()
B19H102

  • Parvovirus B19 nucleic acid IVD, control
Parvovirus B19 Low Run Control
EXACT DIAGNOSTICS, LLC
B19L101
In Commercial Distribution

  • 00812242030482 ()
B19L101

  • Parvovirus B19 nucleic acid IVD, control
Parvovirus B19 Verification Panel
EXACT DIAGNOSTICS, LLC
B19P100
In Commercial Distribution

  • 00812242030475 ()
B19P100

  • Parvovirus B19 nucleic acid IVD, calibrator
HSV-2 High Run Control
EXACT DIAGNOSTICS, LLC
HSV2H102
In Commercial Distribution

  • 00812242030468 ()
HSV2H102

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
HSV-2 Low Run Control
EXACT DIAGNOSTICS, LLC
HSV2L101
In Commercial Distribution

  • 00812242030451 ()
HSV2L101

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
HSV-2 Verification Panel
EXACT DIAGNOSTICS, LLC
HSV2P100
In Commercial Distribution

  • 00812242030444 ()
HSV2P100

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, calibrator
HSV-1 High Run Control
EXACT DIAGNOSTICS, LLC
HSV1H102
In Commercial Distribution

  • 00812242030437 ()
HSV1H102

  • Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD, control
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