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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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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
Babesia Control 1E5 cp/mL
Fort Worth Diagnostics, LLC
BABPOS
In Commercial Distribution

  • 00850051429592 ()
BABPOS

  • Babesia microti nucleic acid IVD, control
Anaplasma Control 1E4 cp/mL
Fort Worth Diagnostics, LLC
ANAPOS
In Commercial Distribution

  • 00850051429585 ()
ANAPOS

  • Anaplasma phagocytophilum nucleic acid IVD, control
Transport Media Dilution Matrix
Fort Worth Diagnostics, LLC
TMNEG
In Commercial Distribution

  • 00850051429578 ()
TMNEG

  • Molecular grade buffered sample diluent IVD
Candida auris Control 5E3 cp/mL
Fort Worth Diagnostics, LLC
CAURPOS
In Commercial Distribution

  • 00850051429561 ()
CAURPOS

  • Multiple Candida species nucleic acid IVD, control
VZV Primer Set
Fort Worth Diagnostics, LLC
VZV003
In Commercial Distribution

  • 00850051429554 ()
VZV003

  • Assay development analyte-specific reagent IVD
Measles Primer Set
Fort Worth Diagnostics, LLC
MEAS002
In Commercial Distribution

  • 00850051429547 ()
MEAS002

  • Assay development analyte-specific reagent IVD
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