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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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Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge - 00842768016950

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)

Dimension N-terminal Pro-Brain Natriuretic Peptide reagent cartridge - 00842768016936

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)

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® TBI/DBI Calibrator - 00842768016813

Bilirubin Calibrator, 2x2x1mL
Siemens Healthcare Diagnostics Inc.
10445013
In Commercial Distribution

  • 00842768016813 ()
DC167

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® CTNI CAL - 00842768016738

Cardiac Troponin I Calibrator, 2x6x1mL
Siemens Healthcare Diagnostics Inc.
10445197
Not in Commercial Distribution

  • 00842768016738 ()
KC678

  • Troponin I 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® System FPSA Flex® Reagent Cartridge - 00842768016677

Free Prostate Specific Antigen Flex® reagent cartridge 80 Test
Siemens Healthcare Diagnostics Inc.
10445091
In Commercial Distribution

  • 00842768016677 ()
  • 00630414601786 ()
K6452

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay

Dimension Vista® System TPSA Flex® Reagent Cartridge - 00842768016660

Total Prostate Specific Antigen Flex® reagent cartridge 120 Test
Siemens Healthcare Diagnostics Inc.
10445090
In Commercial Distribution

  • 00842768016660 ()
  • 00630414601779 ()
K6451

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge FOL - 00842768016653

Folate Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445138
In Commercial Distribution

  • 00842768016653 ()
  • 00630414005072 ()
K6444

  • Folate (vitamin B9) IVD, kit, chemiluminescent immunoassay

Dimension Vista® BHCG CAL - 00842768016516

Beta Human Chorionic Gonadotropin Calibrator, 2x4x1mL / 2x2mL / 2x1.5mL
Siemens Healthcare Diagnostics Inc.
10445192
In Commercial Distribution

  • 00842768016516 ()
KC632

  • Human chorionic gonadotropin beta-subunit (beta-HCG) IVD, calibrator
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