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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 - 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

Exact Diagnostics - 00812242030048

CMV Low Run Control
EXACT DIAGNOSTICS, LLC
CMVL101
In Commercial Distribution

  • 00812242030048 ()
CMVL101

  • Cytomegalovirus (CMV) nucleic acid IVD, control

Exact Diagnostics - 00812242030031

CMV Verification Panel
EXACT DIAGNOSTICS, LLC
CMVP100
In Commercial Distribution

  • 00812242030031 ()
CMVP100

  • Cytomegalovirus (CMV) nucleic acid IVD, calibrator

Exact Diagnostics - 00812242030024

HIV-1 High Run Control
EXACT DIAGNOSTICS, LLC
HIVH102
In Commercial Distribution

  • 00812242030024 ()
HIVH102

  • HIV1 nucleic acid IVD, control

Exact Diagnostics - 00812242030017

HIV-1 Low Run Control
EXACT DIAGNOSTICS, LLC
HIVL101
In Commercial Distribution

  • 00812242030017 ()
HIVL101

  • HIV1 nucleic acid IVD, control

Exact Diagnostics - 00812242030000

HIV-1 Verification Panel
EXACT DIAGNOSTICS, LLC
HIVP100
In Commercial Distribution

  • 00812242030000 ()
HIVP100

  • HIV1 nucleic acid IVD, calibrator

LABType™ HD Class I DRB1 Typing Test - 1000 tests - 00812117017945

DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017945 ()
RSSOH2B1X

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LABType™ HD Class I C Locus Typing Test - 1000 tests - 00812117017938

DNA typing of HLA Class I or Class II alleles.
ONE LAMBDA, INC.
N/A
In Commercial Distribution

  • 00812117017938 ()
RSSOH1CX

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
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