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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® Flex® reagent cartridge LITH - 00842768035326

Lithium Flex® reagent cartridge, 180 tests
Siemens Healthcare Diagnostics Inc.
10635870
In Commercial Distribution

  • 00842768035326 ()
  • 00630414005935 ()
K4150

  • Lithium therapeutic drug monitoring IVD, kit, spectrophotometry

Dimension Vista® DRUG 4 CAL - 00842768035319

Drug 4 Calibrator, 2x5x2.5mL
Siemens Healthcare Diagnostics Inc.
10476171
In Commercial Distribution

  • 00842768035319 ()
KC460A

  • Multiple-therapy therapeutic drug monitoring IVD, calibrator

Dimension Vista® ENZ 2 CAL - 00842768034343

Enzyme 2 Calibrator, 3x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10475527
In Commercial Distribution

  • 00842768034343 ()
KC321

  • Multiple clinical chemistry enzyme IVD, calibrator

Dimension® Flex® reagent cartridge ALTI - 00842768034336

Alanine Aminotransferase Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10475530
In Commercial Distribution

  • 00842768034336 ()
  • 00630414005744 ()
DF143

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry

Dimension® ENZ II CAL - 00842768034329

Enzyme II Calibrator, 2x3x1.5mL
Siemens Healthcare Diagnostics Inc.
10476170
In Commercial Distribution

  • 00842768034329 ()
DC143

  • Multiple clinical chemistry enzyme IVD, calibrator

Dimension Vista® Flex® reagent cartridge ALTI - 00842768034312

Alanine Aminotransferase Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10635565
In Commercial Distribution

  • 00842768034312 ()
  • 00630414005928 ()
K2143

  • Alanine aminotransferase (ALT) IVD, kit, spectrophotometry

Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 4 - 00842768034169

Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 4
Siemens Healthcare Diagnostics Inc.
10470444
In Commercial Distribution

  • 00842768034169 ()
9R589UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 3 - 00842768034152

Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 3
Siemens Healthcare Diagnostics Inc.
10470443
In Commercial Distribution

  • 00842768034152 ()
9R569UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 2 - 00842768034145

Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 2
Siemens Healthcare Diagnostics Inc.
10470442
In Commercial Distribution

  • 00842768034145 ()
9R549UL

  • Multiple drugs of abuse IVD, calibrator

Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1 - 00842768034138

Syva® Emit® II Plus 6-AM /Ecstasy Calibrator/Control Level 1
Siemens Healthcare Diagnostics Inc.
10470441
In Commercial Distribution

  • 00842768034138 ()
9R529UL

  • Multiple drugs of abuse IVD, calibrator
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