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

  • 00812242030093 ()
HCVL101

  • Hepatitis C virus nucleic acid IVD, control
Bulk Negative
EXACT DIAGNOSTICS, LLC
NEG050
In Commercial Distribution

  • 00812242030079 ()
NEG050

  • PCR/NAT negative control IVD
Negative Run Control
EXACT DIAGNOSTICS, LLC
NEG000
In Commercial Distribution

  • 00812242030062 ()
NEG000

  • PCR/NAT negative control IVD
CMV High Run Control
EXACT DIAGNOSTICS, LLC
CMVH102
In Commercial Distribution

  • 00812242030055 ()
CMVH102

  • Cytomegalovirus (CMV) nucleic acid IVD, control
CMV Low Run Control
EXACT DIAGNOSTICS, LLC
CMVL101
In Commercial Distribution

  • 00812242030048 ()
CMVL101

  • Cytomegalovirus (CMV) nucleic acid IVD, control
HIV-1 High Run Control
EXACT DIAGNOSTICS, LLC
HIVH102
In Commercial Distribution

  • 00812242030024 ()
HIVH102

  • HIV1 nucleic acid IVD, control
HIV-1 Low Run Control
EXACT DIAGNOSTICS, LLC
HIVL101
In Commercial Distribution

  • 00812242030017 ()
HIVL101

  • HIV1 nucleic acid IVD, control
Aspergillus Pooled Antiserum, 2mL
MICROBIOLOGICS INC.
200350
Not in Commercial Distribution

  • 10634853000435 ()
200350

  • Multiple Aspergillus species total antibody IVD, control
Aspergillus Pooled Antigen, 1mL
MICROBIOLOGICS INC.
200345
Not in Commercial Distribution

  • 10634853000428 ()
200345

  • Multiple Aspergillus species antigen IVD, control
Aspergillus nidulans Antiserum, 2mL
MICROBIOLOGICS INC.
200290
Not in Commercial Distribution

  • 10634853000411 ()
200290

  • Multiple Aspergillus species total antibody IVD, control
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