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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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HemosIL Heparin Calibrators - 08426950472483

HemosIL Heparin Calibrators
INSTRUMENTATION LABORATORY COMPANY
00020300600
In Commercial Distribution

  • 08426950472483 ()
00020300600

  • Heparin anti-Xa IVD, calibrator

HardyDisk™ - 00816576028368

XV Factor, HardyDisks™, Hemin and NAD disk to aid in the identification of Haemophilus spp., 50 disks per cartridge, 1 each Contains NAD and Hemin (X and V Factors) for the speciation of Haemophilus.
HARDY DIAGNOSTICS
Z7051
In Commercial Distribution

  • 00816576028351 ()
  • 00816576028368 ()
Z7051

  • X/V factor differentiation disc IVD

BIOPHEN UFH Calibrator - 03663537008276

No Description
HYPHEN BIOMED
222301
In Commercial Distribution

  • 03663537008276 ()
222301

  • Heparin anti-Xa IVD, calibrator

BIOPHEN Heparin Calibrator - 03663537008245

No Description
HYPHEN BIOMED
222001
In Commercial Distribution

  • 03663537008245 ()
222001

  • Heparin anti-Xa IVD, calibrator

X & V FACTOR - 05032384105014

No Description
OXOID LIMITED
DD0005B
In Commercial Distribution

  • 05032384105014 ()


  • X/V factor differentiation disc IVD

X & V FACTOR - 05032384034109

No Description
OXOID LIMITED
DD0005T
In Commercial Distribution

  • 05032384034109 ()


  • X/V factor differentiation disc IVD

INNOVANCE Heparin Calibrator - 00630414639833

For calibration of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873925
In Commercial Distribution

  • 00630414639833 ()
10873925

  • Heparin anti-Xa IVD, calibrator

INNOVANCE Heparin Calibrator - 00842768017063

For calibration of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873530
In Commercial Distribution

  • 00842768017063 ()
OPOB05

  • Heparin anti-Xa IVD, calibrator

Berichrom® Heparin UF Calibrator - 00842768006869

For calibration of the Berichrom Heparin assay for measurement of unfractionated heparin
Siemens Healthcare Diagnostics Products GmbH
10445989
Not in Commercial Distribution

  • 00842768006869 ()
  • 00842768019197 ()
OPCC03

  • Heparin anti-Xa IVD, calibrator

Berichrom® Heparin LMW Calibrator - 00842768006845

For calibration of the Berichrom Heparin assay for measurement of low molecular weight heparin
Siemens Healthcare Diagnostics Products GmbH
10445987
Not in Commercial Distribution

  • 00842768006845 ()
  • 00842768019210 ()
OPCA03

  • Heparin anti-Xa IVD, calibrator
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