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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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No Description
HYPHEN BIOMED
223701
In Commercial Distribution

  • 03663537008368 ()
223701

  • Heparin anti-Xa IVD, control
No Description
HYPHEN BIOMED
223101
In Commercial Distribution

  • 03663537008290 ()
223101

  • Heparin anti-Xa IVD, control
No Description
HYPHEN BIOMED
223001
In Commercial Distribution

  • 03663537008283 ()
223001

  • Heparin anti-Xa IVD, control
No Description
HYPHEN BIOMED
223901
In Commercial Distribution

  • 03663537007996 ()
223901

  • Heparin anti-Xa IVD, control
No Description
HYPHEN BIOMED
223801
In Commercial Distribution

  • 03663537007989 ()
223801

  • Heparin anti-Xa IVD, control
For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873534
In Commercial Distribution

  • 00842768017100 ()
  • 00630414229539 ()
OPOE05

  • Heparin anti-Xa IVD, control
For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873533
In Commercial Distribution

  • 00842768017094 ()
  • 00630414229546 ()
OPOF05

  • Heparin anti-Xa IVD, control
For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873532
In Commercial Distribution

  • 00842768017087 ()
  • 00630414229522 ()
OPOD05

  • Heparin anti-Xa IVD, control
For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873531
In Commercial Distribution

  • 00842768017070 ()
  • 00630414229515 ()
OPOC05

  • Heparin anti-Xa IVD, control
George King (GK) Heparin Control Plasma is an assayed citrated plasma intended for the control of Unfractionated Heparin (UFH) activity using an anti-Xa chromogenic assay and coagulation analyzer with appropriate commercial anti-Xa reagents.
GEORGE KING BIO-MEDICAL, INC
7000-1.0
In Commercial Distribution

  • 00815696021327 ()


  • Heparin anti-Xa IVD, control
No Description
OXOID LIMITED
DD0005B
In Commercial Distribution

  • 05032384105014 ()


  • X/V factor differentiation disc IVD
No Description
OXOID LIMITED
DD0005T
In Commercial Distribution

  • 05032384034109 ()


  • X/V factor differentiation disc IVD
For calibration of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873925
In Commercial Distribution

  • 00630414639833 ()
10873925

  • Heparin anti-Xa IVD, calibrator
BD BBL™ Taxo™ Differentiation Discs VX
BECTON, DICKINSON AND COMPANY
231731
In Commercial Distribution

  • 00382902317319 ()
231731

  • X/V factor differentiation disc IVD
BD BBL™ Taxo™ Differentiation Discs X
BECTON, DICKINSON AND COMPANY
231729
In Commercial Distribution

  • 00382902317296 ()
231729

  • X/V factor differentiation disc IVD
BD BBL™ Taxo™ Differentiation Discs V
BECTON, DICKINSON AND COMPANY
231727
In Commercial Distribution

  • 00382902317272 ()
231727

  • X/V factor differentiation disc IVD
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
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
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
HemosIL Heparin Calibrators
INSTRUMENTATION LABORATORY COMPANY
00020300600
In Commercial Distribution

  • 08426950472483 ()
00020300600

  • Heparin anti-Xa IVD, calibrator
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