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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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Syva® Emit® 2000 Cyclosporine Specific Calibrators - 00842768001468

Emit® 2000 Cyclosporine Specific Calibrators, 6 levels
Siemens Healthcare Diagnostics Inc.
10445376
In Commercial Distribution

  • 00842768001468 ()
6R119UL

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Syva® Emit® 2000 Sirolimus Calibrators - 00842768029622

Syva® Emit® 2000 Sirolimus Calibrators
Siemens Healthcare Diagnostics Inc.
10445402
In Commercial Distribution

  • 00842768029622 ()
8S109UL

  • Rapamycin (sirolimus) therapeutic drug monitoring IVD, calibrator

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® CTNI Calibrator - 00842768013713

Cardiac Troponin-I Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10444986
In Commercial Distribution

  • 00842768013713 ()
  • 00630414016955 ()
RC421C

  • Troponin I 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

VITA ADIVA F-CEM White Opaque - EHARFAFCEMWO51

Dual-curing adhesive composite
Harvard Dental International GmbH
FAFCEMWO5
In Commercial Distribution

  • EHARFAFCEMWO51 ()


  • Dental composite resin
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