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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 VALP - 00842768015526

Valproic Acid Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445127
In Commercial Distribution

  • 00842768015526 ()
  • 00630414004983 ()
K4078

  • Valproic acid therapeutic drug monitoring IVD, kit, nephelometry/turbidimetry

Dimension Vista® Flex® reagent cartridge URCA - 00842768015519

Uric Acid Flex® reagent cartridge, 560 tests
Siemens Healthcare Diagnostics Inc.
10445145
In Commercial Distribution

  • 00842768015519 ()
  • 00630414005126 ()
K1077

  • Uric acid IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge UCFP - 00842768015502

Urinary/Cerebrospinal Fluid Protein Flex® reagent cartridge, 180 Tests
Siemens Healthcare Diagnostics Inc.
10445168
In Commercial Distribution

  • 00842768015502 ()
  • 00630414005270 ()
K3026

  • Total protein IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge TU - 00842768015496

Thyronine Uptake Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10445102
In Commercial Distribution

  • 00842768015496 ()
  • 00630414004761 ()
K6075

  • Thyroxine binding globulin (TBG) IVD, kit enzyme immunoassay (EIA)

Dimension Vista® Flex® reagent cartridge TRIG - 00842768015489

Triglyceride Flex® reagent cartridge, 600 tests
Siemens Healthcare Diagnostics Inc.
10445093
In Commercial Distribution

  • 00842768015489 ()
  • 00630414004709 ()
K2069

  • Triglyceride IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge TOBR - 00842768015472

Tobramycin Flex® reagent cartridge, 40 tests
Siemens Healthcare Diagnostics Inc.
10445121
In Commercial Distribution

  • 00842768015472 ()
  • 00630414004945 ()
K4014

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

Dimension Vista® Flex® reagent cartridge TIBC - 00842768015465

Total Iron Binding Capacity Flex® reagent cartridge, 160 Tests
Siemens Healthcare Diagnostics Inc.
10445134
In Commercial Distribution

  • 00842768015465 ()
  • 00630414005041 ()
K3084

  • Total iron binding capacity (TIBC) IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge PCHE - 00842768015373

Pseudocholinesterase Flex® reagent cartridge, 160 tests
Siemens Healthcare Diagnostics Inc.
10445156
In Commercial Distribution

  • 00842768015373 ()
  • 00630414005195 ()
K3051

  • Pseudocholinesterase IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge OPI - 00842768015359

Urine Opiate Screen Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445114
In Commercial Distribution

  • 00842768015359 ()
  • 00630414004877 ()
K5093

  • Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

Dimension Vista® Flex® reagent cartridge MYO - 00842768015335

Myoglobin Flex® reagent cartridge, 100 tests
Siemens Healthcare Diagnostics Inc.
10445099
In Commercial Distribution

  • 00842768015335 ()
  • 00630414004747 ()
K6422

  • Myoglobin IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge MMB - 00842768015328

Mass Creatine Kinase MB Isoenzyme Flex® reagent cartridge, 100 tests
Siemens Healthcare Diagnostics Inc.
10445097
In Commercial Distribution

  • 00842768015328 ()
  • 00630414004723 ()
K6420

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge METH - 00842768015304

Urine Methadone Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445111
In Commercial Distribution

  • 00842768015304 ()
  • 00630414004846 ()
K5090

  • Methadone IVD, kit, enzyme immunoassay (EIA)

Dimension Vista® Flex® reagent cartridge LIDO - 00842768015281

Lidocaine Flex® reagent cartridge, 60 tests
Siemens Healthcare Diagnostics Inc.
10445132
In Commercial Distribution

  • 00842768015281 ()
  • 00630414005034 ()
K4113

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

Dimension Vista® Flex® reagent cartridge LDLC - 00842768015267

Low-Density Lipoprotein Cholesterol Flex® reagent cartridge, 180 Tests
Siemens Healthcare Diagnostics Inc.
10445096
In Commercial Distribution

  • 00842768015267 ()
  • 00630414004716 ()
K3131

  • Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge IRON - 00842768015236

Iron Flex® reagent cartridge, 240 tests
Siemens Healthcare Diagnostics Inc.
10445135
In Commercial Distribution

  • 00842768015236 ()
  • 00630414005058 ()
K3085

  • Iron IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge GGT - 00842768015229

Gamma Glutamyl Transferase Flex® reagent cartridge, 420 tests
Siemens Healthcare Diagnostics Inc.
10445150
In Commercial Distribution

  • 00842768015229 ()
  • 00630414005157 ()
K2045

  • Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry

Dimension Vista® Flex® reagent cartridge GENT - 00842768015212

Gentamicin Flex® reagent cartridge, 40 tests
Siemens Healthcare Diagnostics Inc.
10445120
In Commercial Distribution

  • 00842768015212 ()
  • 00630414004938 ()
K4012

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

Dimension Vista® Flex® reagent cartridge FT4 - 00842768015205

Free Thyroxine Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10445103
In Commercial Distribution

  • 00842768015205 ()
  • 00630414004778 ()
K6410

  • Free thyroxine (FT4) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge FT3 - 00842768015199

Free Triiodothyronine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10445106
In Commercial Distribution

  • 00842768015199 ()
  • 00630414004792 ()
K6416

  • Free triiodothyronine (FT3) IVD, kit, chemiluminescent immunoassay

Dimension Vista® Flex® reagent cartridge FERR - 00842768015182

Ferritin Flex® reagent cartridge, 320 tests
Siemens Healthcare Diagnostics Inc.
10445136
In Commercial Distribution

  • 00842768015182 ()
  • 00630414005065 ()
K6440

  • Ferritin 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 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

Dimension Vista® Flex® reagent cartridge ACTM - 00842768015014

Acetaminophen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10445110
In Commercial Distribution

  • 00842768015014 ()
  • 00630414004839 ()
K5088

  • Acetaminophen IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge EXTC - 00842768014710

Urine Ecstasy Screen Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10444921
In Commercial Distribution

  • 00842768014710 ()
  • 00630414004075 ()
DF109

  • Amphetamine/methamphetamine group IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Methaqualone Assay - 00842768014437

Syva® Emit® II Plus Methaqualone Assay, 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10445474
In Commercial Distribution

  • 00842768014437 ()
9Q039UL

  • Methaqualone IVD, kit, enzyme immunoassay (EIA)
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