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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® LIPL CAL - 00842768025228

Lipase Calibrator, 2x3x1mL
Siemens Healthcare Diagnostics Inc.
10460278
In Commercial Distribution

  • 00842768025228 ()
DC56

  • Lipase IVD, calibrator

Dimension Vista® System DRUG 3 CAL - 00842768025211

Drug 3 Calibrator- Level A - 6x2mL, Level B 3x1.5ml, Level C 3X1.5 mL
Siemens Healthcare Diagnostics Inc.
10285194
Not in Commercial Distribution

  • 00842768025211 ()
KC430A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension® CSA Flex® reagent cartridge - 00842768025136

Cyclosporine Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10285193
In Commercial Distribution

  • 00842768025136 ()
  • 00630414002972 ()
DF89A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Dimension Vista® PNBP CAL - 00842768025129

N-terminal Pro-Brain Natriuretic Peptide Calibrator, 2x6x1mL
Siemens Healthcare Diagnostics Inc.
10464322
In Commercial Distribution

  • 00842768025129 ()
KC676A

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

Dimension Vista® Flex® reagent cartridge PBNP - 00842768025112

NT-proBNP Flex® reagent cartridge, 80 Tests
Siemens Healthcare Diagnostics Inc.
10464321
In Commercial Distribution

  • 00842768025112 ()
  • 00630414005522 ()
K6423A

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay

Stratus® CS - 00842768024863

The Stratus® CS STAT Fluorometric Analyzer is a microprocessor controlled instrument that measures analytes in body fluids for in vitro diagnostic use. The instrument is intended for use by trained healthcare professionals in the clinical laboratory and point of care settings and is intended for the measurement of the following analytes: High Sensitivity Troponin-I (CTNI), CK-MB Mass (Creatine kinase. MB) (CKMB), Myoglobin (MYO), NT-proBNP (PBNP), D-dimer (DDMR), CardioPhase hsCRP (High Sensitiv
Siemens Healthcare Diagnostics Inc.
10444834
In Commercial Distribution

  • 00842768024863 ()
758000.901

  • Fluorescent immunoassay analyser IVD, laboratory, semi-automated

Dimension Vista Barcode Labels - 00842768024719

Dimension Vista Barcode Labels
Siemens Healthcare Diagnostics Inc.
10464353
In Commercial Distribution

  • 00842768024719 ()
KS866

  • Printer label IVD

Dimension Vista® System PSA CAL - 00842768024214

Prostate Specific Antigen Calibrator
Siemens Healthcare Diagnostics Inc.
10464359
In Commercial Distribution

  • 00842768024214 ()
KC602

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Syva® Emit® II 5B3 THC Assay - 00842768023910

Syva® Emit® II 5B3 THC Assay
Siemens Healthcare Diagnostics Inc.
10445468
Not in Commercial Distribution

  • 00842768023910 ()
9M979UL

  • Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

Emit® II Plus Ecstasy Assay - 00842768023460

Emit® II Plus Ecstasy Assay labeled with the Beckman Coulter® name
Siemens Healthcare Diagnostics Inc.
10445479
In Commercial Distribution

  • 00842768023460 ()
9X229

  • Methamphetamine-specific IVD, kit, enzyme immunoassay (EIA)
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