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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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Babesia Primer Set
Fort Worth Diagnostics, LLC
BAB003
In Commercial Distribution

  • 00850051429691 ()
BAB003

  • Assay development analyte-specific reagent IVD
Viral Transport Media Dilution Matrix
Fort Worth Diagnostics, LLC
VTMNEG
In Commercial Distribution

  • 00850051429684 ()
VTMNEG

  • Molecular grade buffered sample diluent IVD
Influenza A H5N1 Primer Set
Fort Worth Diagnostics, LLC
H5N1003
In Commercial Distribution

  • 00850051429677 ()
H5N1003

  • Assay development analyte-specific reagent IVD
Measles Virus Control 1E5 cp/mL
Fort Worth Diagnostics, LLC
MEASPOS
In Commercial Distribution

  • 00850051429660 ()
MEASPOS

  • Measles virus nucleic acid IVD, control
Influenza A H5N1 Control 1E5 cp/mL
Fort Worth Diagnostics, LLC
H5N1POS
In Commercial Distribution

  • 00850051429653 ()
H5N1POS

  • Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, control
Adenovirus Primer Set
Fort Worth Diagnostics, LLC
ADV003
In Commercial Distribution

  • 00850051429646 ()
ADV003

  • Assay development analyte-specific reagent IVD
Stabilized Blood Dilution Matrix
Fort Worth Diagnostics, LLC
SBNEG
In Commercial Distribution

  • 00850051429639 ()
SBNEG

  • Molecular grade buffered sample diluent IVD
B.miyamotoi Control 1E5 cp/mL
Fort Worth Diagnostics, LLC
MIYPOS
In Commercial Distribution

  • 00850051429622 ()
MIYPOS

  • Borrelia burgdorferi nucleic acid IVD, control
Ehrlichia Control 5E4 cp/mL
Fort Worth Diagnostics, LLC
EHRPOS
In Commercial Distribution

  • 00850051429615 ()
EHRPOS

  • Ehrlichia chaffeensis nucleic acid IVD, control
Borrelia Control 2E5 cp/mL
Fort Worth Diagnostics, LLC
BORPOS
In Commercial Distribution

  • 00850051429608 ()
BORPOS

  • Borrelia burgdorferi nucleic acid IVD, control
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