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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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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
JCV High Run Control
EXACT DIAGNOSTICS, LLC
JCVH102
In Commercial Distribution

  • 00812242030543 ()
JCVH102

  • JC virus (JCV) nucleic acid IVD, control
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
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