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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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STA® - HBPM/LMWH Control - 03607450006827

No Description
DIAGNOSTICA STAGO
00682
In Commercial Distribution

  • 03607450006827 ()


  • Heparin anti-Xa IVD, control

STA® - Quality HNF/UFH - 03607450003819

No Description
DIAGNOSTICA STAGO
00381
In Commercial Distribution

  • 03607450003819 ()


  • Heparin anti-Xa IVD, control

George King Heparin Control Plasma - 00815696021327

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

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

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

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

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

HemosIL Heparin Calibrators - 08426950472483

HemosIL Heparin Calibrators
INSTRUMENTATION LABORATORY COMPANY
00020300600
In Commercial Distribution

  • 08426950472483 ()
00020300600

  • Heparin anti-Xa IVD, calibrator
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