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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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Syva® Emit® 2000 Procainamide Calibrators - 00842768000997

Syva® Emit® 2000 Procainamide Calibrators
Siemens Healthcare Diagnostics Inc.
10445319
In Commercial Distribution

  • 00842768000997 ()
4K109UL

  • Procainamide therapeutic drug monitoring IVD, calibrator

Syva® Emit® 2000 Procainamide Assay - 00842768000980

Syva® Emit® 2000 Procainamide Assay
Siemens Healthcare Diagnostics Inc.
10445318
In Commercial Distribution

  • 00842768000980 ()
4K019UL

  • Procainamide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® 2000 Digoxin Calibrators - 00842768000973

Emit ® 2000 Digoxin Calibrators
Siemens Healthcare Diagnostics Inc.
10445316
In Commercial Distribution

  • 00842768000973 ()
4H209UL

  • Digoxin therapeutic drug monitoring IVD, calibrator

Syva® Emit® 2000 Digoxin Assay - 00842768000966

Emit ® 2000 Digoxin Assay
Siemens Healthcare Diagnostics Inc.
10445315
In Commercial Distribution

  • 00842768000966 ()
4H019UL

  • Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® 2000 Valproic Acid Calibrators - 00842768000959

Syva® Emit® 2000 Valproic Acid Calibrators
Siemens Healthcare Diagnostics Inc.
10445313
In Commercial Distribution

  • 00842768000959 ()
4G109UL

  • Valproic acid therapeutic drug monitoring IVD, calibrator

Syva® Emit® 2000 Valproic Acid Assay - 00842768000942

Syva® Emit® 2000 Valproic Acid Assay
Siemens Healthcare Diagnostics Inc.
10445312
In Commercial Distribution

  • 00842768000942 ()
4G019UL

  • Valproic acid therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® Carbamazepine Calibrators - 00842768000935

Syva® Emit® 2000 Carbamazepine Calibrators
Siemens Healthcare Diagnostics Inc.
10445310
In Commercial Distribution

  • 00842768000935 ()
4F109UL

  • Carbamazepine therapeutic drug monitoring IVD, calibrator

Syva® Emit® Carbamazepine Assay - 00842768000928

Syva® Emit® Carbamazepine Assay
Siemens Healthcare Diagnostics Inc.
10445309
In Commercial Distribution

  • 00842768000928 ()
4F019UL

  • Carbamazepine therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Methadone Assay - 00842768000157

Syva® Emit® II Plus Methadone Assay - 1 L Kit
Siemens Healthcare Diagnostics Inc.
10445428
In Commercial Distribution

  • 00842768000157 ()
9E129UL

  • Methadone IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® Ethosuximide Assay - 00842768000140

Syva® Emit® Ethosuximide Assay
Siemens Healthcare Diagnostics Inc.
10445367
In Commercial Distribution

  • 00842768000140 ()
6E119UL

  • Ethosuximide therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus Methadone Assay - 00842768000133

Syva® Emit® II Plus Methadone Assay - 115 mL Kit
Siemens Healthcare Diagnostics Inc.
10445426
In Commercial Distribution

  • 00842768000133 ()
9E029UL

  • Methadone IVD, kit, enzyme immunoassay (EIA)

Dimension® Sample Diluent - 00842768000119

Sample Diluent, 2 bottles, 50 mL per bottle
Siemens Healthcare Diagnostics Inc.
10444875
In Commercial Distribution

  • 00842768000119 ()
  • 00630414016948 ()
791092901

  • Buffered sample diluent IVD

Dimension® Dimension Vista® System Enzyme Diluent - 00842768000102

Enzyme Diluent, 10x10mL
Siemens Healthcare Diagnostics Inc.
10444870
In Commercial Distribution

  • 00842768000102 ()
  • 00630414003771 ()
790035901

  • Buffered sample diluent IVD

Dimension® Purified Water Diluent - 00842768000096

Purified Water Diluent, 3.5 Liter
Siemens Healthcare Diagnostics Inc.
10444887
In Commercial Distribution

  • 00842768000096 ()
710615901

  • Buffered sample diluent IVD

Dimension Vista® ALPI CAL - 00842768039041

Alkaline Phosphatase Calibrator, 3 x 1mL
Siemens Healthcare Diagnostics Inc.
10714029
In Commercial Distribution

  • 00842768039041 ()
KC331

  • Alkaline phosphatase (ALP) isoenzyme IVD, calibrator

Dimension Vista® Flex® reagent cartridge ALPI - 00842768039034

Alkaline Phosphatase Flex® reagent cartridge, 1600 tests
Siemens Healthcare Diagnostics Inc.
10642444
In Commercial Distribution

  • 00842768039034 ()
  • 00630414005942 ()
K2115

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

Dimension® ALPI CAL - 00842768039027

Alkaline Phosphatase calibrator, 3x2x1mL
Siemens Healthcare Diagnostics Inc.
10714028
In Commercial Distribution

  • 00842768039027 ()
DC150

  • Alkaline phosphatase (ALP) isoenzyme IVD, calibrator

Dimension® Flex® reagent cartridge ALPI - 00842768039010

Alkaline Phosphatase Flex® reagent cartridge, 360 tests
Siemens Healthcare Diagnostics Inc.
10642445
In Commercial Distribution

  • 00842768039010 ()
  • 00630414005959 ()
DF150

  • Total alkaline phosphatase (ALP) IVD, kit, spectrophotometry

Dimension Vista® Acid Clean Flex® reagent cartridge, ACLN - 00842768037771

Dimension Vista® ACLN Flex® reagent cartridge, 4 Flex® reagent cartridges per carton
Siemens Healthcare Diagnostics Inc.
10712182
In Commercial Distribution

  • 00842768037771 ()
  • 00630414016795 ()
KS343

  • Wash/cleaning solution IVD, automated/semi-automated system

Dimension® EXL™ Total Vitamin D - 00842768037740

Dimension® EXL™ Total Vitamin D, 200 tests (4x50)
Siemens Healthcare Diagnostics Inc.
10706480
In Commercial Distribution

  • 00842768037740 ()
  • 00630414016801 ()
RF634

  • Multiple form 25-hydroxy vitamin D IVD, kit, chemiluminescent immunoassay

Dimension EXL LOCI Troponin I High Sensitive - 00842768037726

LOCI High-Sensitivity Troponin I (TNIH)
Siemens Healthcare Diagnostics Inc.
10471068
In Commercial Distribution

  • 00842768037726 ()
  • 00630414225203 ()
RF627

  • Troponin I IVD, kit, chemiluminescent immunoassay

Dimension Vista Troponin I High Sensitive - 00842768037719

High-Sensitivity Troponin (TNIH) Dimension Vista - RGT 120T
Siemens Healthcare Diagnostics Inc.
10471067
In Commercial Distribution

  • 00842768037719 ()
  • 00630414225197 ()
K6427

  • Troponin I IVD, kit, chemiluminescent immunoassay

Dimension Vista® / Dimension® EXL™ LCTNI CON H - 00842768037535

LOCI Cardiac Troponin-I Control (high), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707958
Not in Commercial Distribution

  • 00842768037535 ()
  • 00630414006017 ()
KC683

  • Troponin I IVD, control

Dimension Vista® / Dimension® EXL™ LCTNI CON M - 00842768037528

LOCI Cardiac Troponin-I Control (medium), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707957
Not in Commercial Distribution

  • 00842768037528 ()
  • 00630414006000 ()
KC682

  • Troponin I IVD, control

Dimension Vista® / Dimension® EXL™ LCTNI CON L - 00842768037511

LOCI Cardiac Troponin-I Control (low), 12 vials x2.2mL
Siemens Healthcare Diagnostics Inc.
10707956
Not in Commercial Distribution

  • 00842768037511 ()
  • 00630414005997 ()
KC681

  • Troponin I IVD, control

Dimension® EXL™ 200 Integrated Chemistry System - 00842768037214

Dimension® EXL™ 200 System
Siemens Healthcare Diagnostics Inc.
10636928
In Commercial Distribution

  • 00842768037214 ()
778041.931

  • Multiple clinical chemistry analyser IVD, laboratory

Dimension Vista® Flex® reagent cartridge ECREA - 00842768036262

Enzymatic Creatinine Flex® reagent cartridge, 800 Tests
Siemens Healthcare Diagnostics Inc.
10700444
In Commercial Distribution

  • 00842768036262 ()
  • 00630414005973 ()
K1270A

  • Creatinine IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge MPAT - 00842768036217

Mycophenolic Acid Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10706859
In Commercial Distribution

  • 00842768036217 ()
DF215

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

Dimension® TAC Calibrator - 00842768035432

Tacrolimus Calibrator, Levels 1-5, 2 bottles each
Siemens Healthcare Diagnostics Inc.
10700796
In Commercial Distribution

  • 00842768035432 ()
DC207

  • Tacrolimus therapeutic drug monitoring IVD, calibrator

Dimension® Flex® reagent cartridge TAC - 00842768035425

Tacrolimus Flex® reagent cartridge, TAC, 80 tests (4 x 20)
Siemens Healthcare Diagnostics Inc.
10700795
In Commercial Distribution

  • 00842768035425 ()
  • 00630414005980 ()
DF207

  • Tacrolimus therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

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

Syva® Emit® II Plus 6-Acetylmorphine Assay - 00842768034121

Syva® Emit® II Plus 6-Acetylmorphine Assay - 1 L kit
Siemens Healthcare Diagnostics Inc.
10481483
In Commercial Distribution

  • 00842768034121 ()
9R129UL

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)

Syva® Emit® II Plus 6-Acetylmorphine Assay - 00842768034114

Syva® Emit® II Plus 6-Acetylmorphine Assay - 28 mL Kit
Siemens Healthcare Diagnostics Inc.
10470440
In Commercial Distribution

  • 00842768034114 ()
9R039UL

  • 6-Acetyl morphine IVD, kit, enzyme immunoassay (EIA)

Dimension Vista® LOCI 4 CAL - 00842768033827

LOCI 4 Calibrator, 10 (2A x 2.0 mL; 2B x 2.0 mL; 2C x 2.0 mL;2D x 2.0 mL; 2E x 2.0 mL)
Siemens Healthcare Diagnostics Inc.
10476172
In Commercial Distribution

  • 00842768033827 ()
KC640A

  • Multiple-type clinical chemistry analyte profile IVD, calibrator

Dimension Vista® Flex® reagent cartridge VB12 - 00842768033810

LOCI Vitamin B12 Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10475489
In Commercial Distribution

  • 00842768033810 ()
  • 00630414005737 ()
K6442A

  • Vitamin B12 IVD, kit, chemiluminescent immunoassay

Dimension Vista® DGTX CAL - 00842768033322

DGTX Calibrator, 2x5x5.0mL
Siemens Healthcare Diagnostics Inc.
10636333
In Commercial Distribution

  • 00842768033322 ()
KC470

  • Digitoxin therapeutic drug monitoring IVD, calibrator

Dimension Vista® Flex® reagent cartridge DGTX - 00842768033315

Digitoxin Flex® reagent cartridge, 40 tests
Siemens Healthcare Diagnostics Inc.
10482947
In Commercial Distribution

  • 00842768033315 ()
  • 00630414005775 ()
K4036A

  • Digitoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Dimension® Flex® reagent cartridge CHK - 00842768033124

CHK Flex® reagent cartridge, 8 Flex® reagent cartridges
Siemens Healthcare Diagnostics Inc.
10481507
In Commercial Distribution

  • 00842768033124 ()
  • 00630414005751 ()
DF179

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use

Dimension Vista® Flex® reagent cartridge CHK - 00842768033117

CHK Flex® reagent cartridge, 4 Flex® reagent cartridge
Siemens Healthcare Diagnostics Inc.
10481508
In Commercial Distribution

  • 00842768033117 ()
  • 00630414005768 ()
KS996

  • Optical laboratory instrument performance standard calibrator/control IVD, single-use

Dimension® EXL™ LOCI® Module Flex® reagent cartridge FT3 - 00842768032622

LOCI Free Triiodothyronine Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10483414
In Commercial Distribution

  • 00842768032622 ()
  • 00630414005782 ()
RF616

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

Dimension® Flex Reagent Cartridge HB1C - 00842768032615

Hemoglobin B1c Flex® reagent cartridges, HB1C Calibrator
Siemens Healthcare Diagnostics Inc.
10483822
Not in Commercial Distribution

  • 00842768032615 ()
  • 00630414005805 ()
DF105A

  • Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
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