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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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Carcinoembryonic Antigen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10461744
In Commercial Distribution

  • 00842768019920 ()
  • 00630414005478 ()
K6453

  • Carcinoembryonic antigen (CEA) IVD, kit, chemiluminescent immunoassay
Ethyl Alcohol Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10445109
In Commercial Distribution

  • 00842768019913 ()
  • 00630414004822 ()
K5022

  • Ethanol (ETOH) IVD, kit, spectrophotometry
The Stratus® CS Acute Care™ NT-proBNP Calibrator (pBNP CalPak) is an in vitro diagnostic product intended to be used for the calibration of the Stratus® CS Acute Care™ pBNP method.
Siemens Healthcare Diagnostics Inc.
10445087
In Commercial Distribution

  • 00842768019722 ()
  • 00630414009971 ()
CPBNPM-C

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
The Stratus® CS Acute Care(TM) NT-proBNP method (pBNP) is an in vitro diagnostic test for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in heparinized plasma and is intended to be used on the Stratus® CS analyzer.
Siemens Healthcare Diagnostics Inc.
10445086
In Commercial Distribution

  • 00842768019715 ()
  • 00630414009964 ()
CPBNPM

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, fluorescent immunoassay
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
Mass Creatine Kinase MB Isoenzyme Calibrator, 2x4x1mL / 2x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10445195
In Commercial Distribution

  • 00842768017919 ()
KC672

  • Creatine kinase myocardial isoenzyme (CKMB) 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)
Syva® Emit ® d.a.u.® Amphetamine Class Assay
Siemens Healthcare Diagnostics Inc.
10445253
In Commercial Distribution

  • 00842768017148 ()
3C019UL

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)
LPBN (N-terminal ProBrain Natriuretic Peptide) Flex® reagent cartridge, 72 tests
Siemens Healthcare Diagnostics Inc.
10444900
In Commercial Distribution

  • 00842768016950 ()
  • 00630414003894 ()
RF523A

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, enzyme immunoassay (EIA)
PBNP Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10444901
In Commercial Distribution

  • 00842768016936 ()
  • 00630414003900 ()
RF423A

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, enzyme immunoassay (EIA)
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
Bilirubin Calibrator, 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10445013
In Commercial Distribution

  • 00842768016813 ()
DC167

  • Multiple-type clinical chemistry analyte profile IVD, calibrator
Cardiac Troponin I Calibrator, 2x6x1mL
Siemens Healthcare Diagnostics Inc.
10445197
Not in Commercial Distribution

  • 00842768016738 ()
KC678

  • Troponin I IVD, calibrator
LOCI 1 Calibrator, 2x4x1.5mL / 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10445194
In Commercial Distribution

  • 00842768016714 ()
KC660

  • Multiple thyroid marker IVD, calibrator
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