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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 Vista® LIPID CAL - 00842768020452

Lipid Calibrator, 3x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10464345
In Commercial Distribution

  • 00842768020452 ()
KC220A

  • Multiple lipid analyte IVD, calibrator

Dimension Vista® Flex® reagent cartridge HDLC - 00842768020438

High Density Lipoprotein Cholesterol Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10464340
In Commercial Distribution

  • 00842768020438 ()
  • 00630414005584 ()
K3048A

  • High density lipoprotein (HDL) cholesterol IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge IRON - 00842768020414

Iron Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10444945
In Commercial Distribution

  • 00842768020414 ()
  • 00630414004327 ()
DF85

  • Iron IVD, kit, spectrophotometry

Syva® Emit® II LSD Assay - 00842768020315

Syva® Emit® II LSD Assay
Siemens Healthcare Diagnostics Inc.
10445455
In Commercial Distribution

  • 00842768020315 ()
9L039UL

  • Lysergic acid diethylamide (LSD)/LSD metabolite IVD, kit, enzyme immunoassay (EIA)

Dimension Vista® Flex® reagent cartridge LIPL - 00842768020223

Liquid Lipase Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10461745
Not in Commercial Distribution

  • 00842768020223 ()
  • 00630414005485 ()
K3056

  • Lipase IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge AFP - 00842768019937

Alpha-Fetoprotein Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10463378
In Commercial Distribution

  • 00842768019937 ()
  • 00630414005515 ()
K6454

  • Alpha-fetoprotein (AFP) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge CEA - 00842768019920

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

Dimension Vista® Flex® reagent cartridge ETOH - 00842768019913

Ethyl Alcohol Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10445109
In Commercial Distribution

  • 00842768019913 ()
  • 00630414004822 ()
K5022

  • Ethanol (ETOH) IVD, kit, spectrophotometry

Stratus® CS Acute Care™ pBNP CalPak - 00842768019722

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

Stratus® CS Acute Care™ pBNP TestPak - 00842768019715

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

Dimension® IRON Calibrator - 00842768019616

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

  • 00842768019616 ()
DC85

  • Iron IVD, calibrator

Dimension® Flex® reagent cartridge TACR - 00842768018312

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)

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 Vista® MMB CAL - 00842768017919

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

Syva® Emit® 2000 N-Acetylprocainamide Assay - 00842768017421

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 - 00842768017414

Syva® Emit® 2000 Phenobarbital Calibrators
Siemens Healthcare Diagnostics Inc.
10445307
In Commercial Distribution

  • 00842768017414 ()
4D109UL

  • Phenobarbital IVD, calibrator

Syva® Emit® 2000 Phenobarbital Assay - 00842768017407

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 - 00842768017391

Syva® Emit® 2000 Phenytoin Calibrators
Siemens Healthcare Diagnostics Inc.
10445304
In Commercial Distribution

  • 00842768017391 ()
4A109UL

  • Phenytoin therapeutic drug monitoring IVD, calibrator

Syva® Emit® 2000 Phenytoin Assay - 00842768017384

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 - 00842768017148

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)

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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