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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® TNI CAL - 00842768022074

LOCI Cardiac Troponin I Calibrator, 2x5x2mL
Siemens Healthcare Diagnostics Inc.
10464336
In Commercial Distribution

  • 00842768022074 ()
RC621

  • Troponin I IVD, calibrator

Dimension® Flex® reagent cartridge ETOH - 00842768022050

Ethyl Alcohol Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10459408
In Commercial Distribution

  • 00842768022050 ()
  • 00630414005447 ()
DF22

  • Ethanol (ETOH) IVD, kit, spectrophotometry

Dimension® AHDL CAL - 00842768022012

AHDL Calibrator, 2x3x1mL
Siemens Healthcare Diagnostics Inc.
10464328
In Commercial Distribution

  • 00842768022012 ()
DC48B

  • High density lipoprotein (HDL) cholesterol IVD, calibrator

Dimension Vista® LIPID CAL - 00842768020452

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

  • 00842768020452 ()
KC220A

  • Multiple lipid analyte IVD, calibrator

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 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 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

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® 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)
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