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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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Fort Worth Diagnostics - 00850051429264

Candida glabrata Primer Set
Fort Worth Diagnostics, LLC
GLA002
In Commercial Distribution

  • 00850051429264 ()
GLA002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429257

BVAB2 Primer Set
Fort Worth Diagnostics, LLC
BVAB002
In Commercial Distribution

  • 00850051429257 ()
BVAB002

  • Assay development analyte-specific reagent IVD

Fort Worth Diagnostics - 00850051429233

Borrelia Primer Set
Fort Worth Diagnostics, LLC
BOR002
In Commercial Distribution

  • 00850051429233 ()
BOR002

  • Assay development analyte-specific reagent IVD

Dimension® CSAE Calibrator - 00842768018213

Cyclosporine Extended Range Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445004
Not in Commercial Distribution

  • 00842768018213 ()
  • 00630414017075 ()
DC108A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension® PBNP Calibrator - 00842768016912

N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10445008
In Commercial Distribution

  • 00842768016912 ()
  • 00630414017105 ()
RC423A

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

Dimension Vista® LOCI 1 CAL - 00842768016714

LOCI 1 Calibrator, 2x4x1.5mL / 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10445194
In Commercial Distribution

  • 00842768016714 ()
KC660

  • Multiple thyroid marker IVD, calibrator

Dimension Vista® MYO CAL - 00842768016509

Myoglobin Calibrator, 2x1.5mL / 2x2.5mL / 2x2.0mL
Siemens Healthcare Diagnostics Inc.
10445191
In Commercial Distribution

  • 00842768016509 ()
KC624

  • Myoglobin IVD, calibrator

Dimension Vista® CSAE CAL - 00842768016448

Cyclosporine Extended Range Calibrator, 3x2mL / 3x1.5ml
Siemens Healthcare Diagnostics Inc.
10445186
Not in Commercial Distribution

  • 00842768016448 ()
KC440

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension® CSA Calibrator - 00842768005213

Cyclosporine Calibrator, 1x5x2mL
Siemens Healthcare Diagnostics Inc.
10445001
In Commercial Distribution

  • 00842768005213 ()
DC89

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension® TACR Calibrator - 00842768004872

Tacrolimus Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10445012
Not in Commercial Distribution

  • 00842768004872 ()
DC107

  • Tacrolimus therapeutic drug monitoring IVD, calibrator
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