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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® CKI/MBI CAL - 00842768025549

CKI/MBI Calibrator, 2x2x2mL
Siemens Healthcare Diagnostics Inc.
10464508
In Commercial Distribution

  • 00842768025549 ()
DC32

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, calibrator

Dimension® Flex® reagent cartridge LIPL - 00842768025532

Lipase Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10460277
In Commercial Distribution

  • 00842768025532 ()
  • 00630414005454 ()
DF56

  • Lipase IVD, kit, spectrophotometry

Dimension® Flex® reagent cartridge CKI - 00842768025525

Creatine Kinase Flex® reagent cartridge, 480 tests
Siemens Healthcare Diagnostics Inc.
10464511
In Commercial Distribution

  • 00842768025525 ()
  • 00630414005645 ()
DF38

  • Total creatine kinase (CK) IVD, kit, spectrophotometry

Dimension Vista® ECREA CAL - 00842768025419

Enzymatic Creatinine Calibrator, 3x2x2.5mL
Siemens Healthcare Diagnostics Inc.
10464578
Not in Commercial Distribution

  • 00842768025419 ()
KC270

  • Creatinine IVD, calibrator

ADVIA Centaur® Zika Ab Quality Control - 00842768025273

ADVIA Centaur Zika Test - Zika Ab Controls
Siemens Healthcare Diagnostics Inc.
11200712
Not in Commercial Distribution

  • 00842768025273 ()
11200712

  • Zika virus immunoglobulin M (IgM) antibody IVD, control

Dimension® LIPL CAL - 00842768025228

Lipase Calibrator, 2x3x1mL
Siemens Healthcare Diagnostics Inc.
10460278
In Commercial Distribution

  • 00842768025228 ()
DC56

  • Lipase IVD, calibrator

Dimension Vista® System DRUG 3 CAL - 00842768025211

Drug 3 Calibrator- Level A - 6x2mL, Level B 3x1.5ml, Level C 3X1.5 mL
Siemens Healthcare Diagnostics Inc.
10285194
Not in Commercial Distribution

  • 00842768025211 ()
KC430A

  • Cyclosporin A/cyclosporine therapeutic drug monitoring IVD, calibrator

Dimension® CSA Flex® reagent cartridge - 00842768025136

Cyclosporine Flex® reagent cartridge, 80 tests
Siemens Healthcare Diagnostics Inc.
10285193
In Commercial Distribution

  • 00842768025136 ()
  • 00630414002972 ()
DF89A

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

Dimension Vista® PNBP CAL - 00842768025129

N-terminal Pro-Brain Natriuretic Peptide Calibrator, 2x6x1mL
Siemens Healthcare Diagnostics Inc.
10464322
In Commercial Distribution

  • 00842768025129 ()
KC676A

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, calibrator

Dimension Vista® Flex® reagent cartridge PBNP - 00842768025112

NT-proBNP Flex® reagent cartridge, 80 Tests
Siemens Healthcare Diagnostics Inc.
10464321
In Commercial Distribution

  • 00842768025112 ()
  • 00630414005522 ()
K6423A

  • B-type natriuretic protein/N-terminal pro b-type natriuretic peptide IVD, kit, chemiluminescent immunoassay
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