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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 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)
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