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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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Exact Diagnostics - 00812242030505

Enterovirus Run Control
EXACT DIAGNOSTICS, LLC
EVRC
In Commercial Distribution

  • 00812242030505 ()
EVRC

  • Multiple-type meningitis-associated microorganism nucleic acid IVD, control

Exact Diagnostics - 00812242030499

Parvovirus B19 High Run Control
EXACT DIAGNOSTICS, LLC
B19H102
In Commercial Distribution

  • 00812242030499 ()
B19H102

  • Parvovirus B19 nucleic acid IVD, control

Exact Diagnostics - 00812242030482

Parvovirus B19 Low Run Control
EXACT DIAGNOSTICS, LLC
B19L101
In Commercial Distribution

  • 00812242030482 ()
B19L101

  • Parvovirus B19 nucleic acid IVD, control

Exact Diagnostics - 00812242030475

Parvovirus B19 Verification Panel
EXACT DIAGNOSTICS, LLC
B19P100
In Commercial Distribution

  • 00812242030475 ()
B19P100

  • Parvovirus B19 nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030109

HCV High Run Control
EXACT DIAGNOSTICS, LLC
HCVH102
In Commercial Distribution

  • 00812242030109 ()
HCVH102

  • Hepatitis C virus nucleic acid IVD, control

Exact Diagnostics - 00812242030093

HCV Low Run Control
EXACT DIAGNOSTICS, LLC
HCVL101
In Commercial Distribution

  • 00812242030093 ()
HCVL101

  • Hepatitis C virus nucleic acid IVD, control

Exact Diagnostics - 00812242030086

HCV Verification Panel
EXACT DIAGNOSTICS, LLC
HCVP100
In Commercial Distribution

  • 00812242030086 ()
HCVP100

  • Hepatitis C virus nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030079

Bulk Negative
EXACT DIAGNOSTICS, LLC
NEG050
In Commercial Distribution

  • 00812242030079 ()
NEG050

  • PCR/NAT negative control IVD

Exact Diagnostics - 00812242030062

Negative Run Control
EXACT DIAGNOSTICS, LLC
NEG000
In Commercial Distribution

  • 00812242030062 ()
NEG000

  • PCR/NAT negative control IVD

Exact Diagnostics - 00812242030055

CMV High Run Control
EXACT DIAGNOSTICS, LLC
CMVH102
In Commercial Distribution

  • 00812242030055 ()
CMVH102

  • Cytomegalovirus (CMV) nucleic acid IVD, control
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