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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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Elecsys Troponin T Gen 5 - 07613336158951

Troponin T G5 STAT Elecsys cobas e100 V2 (E1G)
Roche Diagnostics GmbH
08469865160
In Commercial Distribution

  • 07613336158951 ()
08469865160

  • Troponin T IVD, reagent

CalSet Troponin T Gen 5 - 07613336148280

No Description
Roche Diagnostics GmbH
08250499160
In Commercial Distribution

  • 07613336148280 ()
08250499160

  • Troponin T IVD, calibrator

Elecsys Troponin T Gen 5 - 07613336148273

No Description
Roche Diagnostics GmbH
08250472160
In Commercial Distribution

  • 07613336148273 ()
08250472160

  • Troponin T IVD, kit, enzyme immunoassay (EIA)

ASSY,Reag.Disp.Card,PrepKit 5,BenchMark - 07613336125373

No Description
Ventana Medical Systems, Inc.
05251362001
In Commercial Distribution

  • 07613336125373 ()
05251362001

  • Assay container IVD, single-use

NexES Dispenser Card Fixative 5 - 07613336125137

No Description
Ventana Medical Systems, Inc.
05271665001
In Commercial Distribution

  • 07613336125137 ()
05271665001

  • Assay container IVD, single-use

NexES Dispenser Card Option 5 - 07613336125045

No Description
Ventana Medical Systems, Inc.
05271886001
In Commercial Distribution

  • 07613336125045 ()
05271886001

  • Assay container IVD, single-use

NexES Dispenser Card Enzyme 5 - 07613336124956

No Description
Ventana Medical Systems, Inc.
05271550001
In Commercial Distribution

  • 07613336124956 ()
05271550001

  • Assay container IVD, single-use

NexES Dispenser Card Counterstain 5 - 07613336124840

No Description
Ventana Medical Systems, Inc.
05271762001
In Commercial Distribution

  • 07613336124840 ()
05271762001

  • Assay container IVD, single-use

Barbiturate DAU Calibrator, Calibrator #5 - B07601450

5mL/bottle. Concentration: 1000 ng/mL of Secobarbital.
LIN-ZHI INTERNATIONAL, INC.
0145
In Commercial Distribution

  • B07601450 ()
0145

  • Barbiturate IVD, calibrator

Benzodiazepine DAU Calibrator, Calibrator #5 - B07601350

5mL/bottle. Concentration: 1000 ng/mL of Oxazepam.
LIN-ZHI INTERNATIONAL, INC.
0135
In Commercial Distribution

  • B07601350 ()
0135

  • Benzodiazepine group IVD, calibrator
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