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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 CTNI - 00842768015151

Cardiac Troponin I Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445098
Not in Commercial Distribution

  • 00842768015151 ()
  • 00630414004730 ()
K6421

  • Troponin I IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge CSA - 00842768015144

Cyclosporine Flex® reagent cartridge, 60 tests
Siemens Healthcare Diagnostics Inc.
10445139
Not in Commercial Distribution

  • 00842768015144 ()
  • 00630414005089 ()
K4089

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

Dimension Vista® Flex® reagent cartridge CRBM - 00842768015137

Carbamazepine Flex® reagent cartridgem, 80 tests
Siemens Healthcare Diagnostics Inc.
10445129
In Commercial Distribution

  • 00842768015137 ()
  • 00630414005003 ()
K4087

  • Carbamazepine therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Dimension Vista® Flex® reagent cartridge COC - 00842768015120

Urine Cocaine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445113
In Commercial Distribution

  • 00842768015120 ()
  • 00630414004860 ()
K5092

  • Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),

Dimension Vista® Flex® reagent cartridge CHOL - 00842768015090

Cholesterol Flex® reagent cartridge, 600 tests
Siemens Healthcare Diagnostics Inc.
10445143
In Commercial Distribution

  • 00842768015090 ()
  • 00630414005102 ()
K1027

  • Total cholesterol lipid IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge BENZ - 00842768015083

Urine Benzodiazepines Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445118
In Commercial Distribution

  • 00842768015083 ()
  • 00630414004914 ()
K5097

  • Benzodiazepine group IVD, kit, enzyme immunoassay (EIA)

Dimension Vista® Flex® reagent cartridge BARB - 00842768015076

Urine Barbiturates Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445117
In Commercial Distribution

  • 00842768015076 ()
  • 00630414004907 ()
K5096

  • Barbiturate IVD, kit, enzyme immunoassay (EIA)

Dimension Vista® Flex® reagent cartridge AMY - 00842768015069

Amylase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10445154
In Commercial Distribution

  • 00842768015069 ()
  • 00630414005188 ()
K3017

  • Total amylase IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge AMPH - 00842768015052

Urine Amphetamine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445112
In Commercial Distribution

  • 00842768015052 ()
  • 00630414004853 ()
K5091

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

Dimension Vista® Flex® reagent cartridge ALB - 00842768015021

Albumin Flex® reagent cartridge, 1200 tests
Siemens Healthcare Diagnostics Inc.
10445165
In Commercial Distribution

  • 00842768015021 ()
  • 00630414005256 ()
K1013

  • Albumin IVD, kit, spectrophotometry
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