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 Class Implantable

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IRON Calibrator, 2x2x1.2mL
Siemens Healthcare Diagnostics Inc.
10445010
In Commercial Distribution

  • 00842768019616 ()
DC85

  • Iron IVD, calibrator
Total Bilirubin Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444938
Not in Commercial Distribution

  • 00842768018312 ()
  • 00630414004259 ()
DF107

  • Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
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
Emit ® 2000 N-Acetylprocainamide Assay
Siemens Healthcare Diagnostics Inc.
10445321
In Commercial Distribution

  • 00842768017421 ()
4N019UL

  • N-acetyl procainamide (NAPA) IVD, kit, fluorescent immunoassay
Syva® Emit® 2000 Phenobarbital Calibrators
Siemens Healthcare Diagnostics Inc.
10445307
In Commercial Distribution

  • 00842768017414 ()
4D109UL

  • Phenobarbital IVD, calibrator
Emit ® 2000 Phenobarbital Assay
Siemens Healthcare Diagnostics Inc.
10445306
In Commercial Distribution

  • 00842768017407 ()
4D019UL

  • Phenobarbital IVD, kit, enzyme immunoassay (EIA)
Syva® Emit® 2000 Phenytoin Calibrators
Siemens Healthcare Diagnostics Inc.
10445304
In Commercial Distribution

  • 00842768017391 ()
4A109UL

  • Phenytoin therapeutic drug monitoring IVD, calibrator
Emit ® 2000 Phenytoin Assay
Siemens Healthcare Diagnostics Inc.
10445303
In Commercial Distribution

  • 00842768017384 ()
4A019UL

  • Phenytoin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Total Iron Binding Capacity Calibrator, 3x1mL
Siemens Healthcare Diagnostics Inc.
10445175
In Commercial Distribution

  • 00842768015847 ()
KC230

  • Total iron binding capacity (TIBC) IVD, calibrator
Bilirubin Calibrator, 3x2.5 mL
Siemens Healthcare Diagnostics Inc.
10460279
In Commercial Distribution

  • 00842768015823 ()
KC210

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
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