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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 FSH - 00842768026430

LOCI Follicle Stimulating Hormone Flex® reagent cartridge, 200 tests
Siemens Healthcare Diagnostics Inc.
10488533
In Commercial Distribution

  • 00842768026430 ()
  • 00630414005829 ()
K6460

  • Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

Dimension® NTP CAL - 00842768026324

LOCI N-Terminal Pro-Brain Natriuretic Peptide Calibrator, 2x5x1mL
Siemens Healthcare Diagnostics Inc.
10464529
In Commercial Distribution

  • 00842768026324 ()
RC623

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

Dimension® ENZ 1 CAL - 00842768026218

Enzyme I Calibrator, 2x2x1.5mL
Siemens Healthcare Diagnostics Inc.
10284680
In Commercial Distribution

  • 00842768026218 ()
  • 00630414602004 ()
DC35

  • Multiple clinical chemistry enzyme IVD, calibrator

Dimension® Flex® reagent cartridge MBI - 00842768025556

Creatine Kinase MB Flex® reagent cartridge, 120 tests
Siemens Healthcare Diagnostics Inc.
10464510
In Commercial Distribution

  • 00842768025556 ()
  • 00630414005638 ()
DF32

  • Creatine kinase myocardial isoenzyme (CKMB) IVD, kit, spectrophotometry

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
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