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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
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
Control Plasma LMW Heparin
INSTRUMENTATION LABORATORY COMPANY
82 3492 63
Not in Commercial Distribution

  • 08426950083597 ()
82 3492 63

  • Heparin anti-Xa IVD, control
No Description
DIAGNOSTICA STAGO
00381
In Commercial Distribution

  • 03607450003819 ()


  • Heparin anti-Xa IVD, control
No Description
DIAGNOSTICA STAGO
00686
In Commercial Distribution

  • 03607450006865 ()


  • Heparin anti-Xa IVD, control
No Description
DIAGNOSTICA STAGO
00683
In Commercial Distribution

  • 03607450006834 ()


  • Heparin anti-Xa IVD, control
No Description
DIAGNOSTICA STAGO
00682
In Commercial Distribution

  • 03607450006827 ()


  • Heparin anti-Xa IVD, control
HemosIL UF Heparin Controls
INSTRUMENTATION LABORATORY COMPANY
00020300300
In Commercial Distribution

  • 08426950478683 ()
  • 18426950478680 ()
00020300300

  • Heparin anti-Xa IVD, control
HemosIL LMW Heparin Controls
INSTRUMENTATION LABORATORY COMPANY
00020300200
In Commercial Distribution

  • 08426950472490 ()
00020300200

  • 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
For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873929
In Commercial Distribution

  • 00630414229539 ()
  • 00630414639956 ()
10873929

  • Heparin anti-Xa IVD, control
For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873926
In Commercial Distribution

  • 00630414229515 ()
  • 00630414639949 ()
10873926

  • Heparin anti-Xa IVD, control
For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873928
In Commercial Distribution

  • 00630414229546 ()
  • 00630414639857 ()
10873928

  • Heparin anti-Xa IVD, control
For quality control of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873927
In Commercial Distribution

  • 00630414229522 ()
  • 00630414639840 ()
10873927

  • 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
HYPHEN BIOMED
222301
In Commercial Distribution

  • 03663537008276 ()
222301

  • Heparin anti-Xa IVD, calibrator
No Description
HYPHEN BIOMED
222001
In Commercial Distribution

  • 03663537008245 ()
222001

  • Heparin anti-Xa IVD, calibrator
No Description
DIAGNOSTICA STAGO
00348
In Commercial Distribution

  • 03607450003482 ()


  • Heparin anti-Xa IVD, calibrator
No Description
DIAGNOSTICA STAGO
00684
In Commercial Distribution

  • 03607450006841 ()


  • Heparin anti-Xa IVD, calibrator
No Description
DIAGNOSTICA STAGO
00681
In Commercial Distribution

  • 03607450006810 ()


  • Heparin anti-Xa IVD, calibrator
HemosIL Heparin Calibrators
INSTRUMENTATION LABORATORY COMPANY
00020300600
In Commercial Distribution

  • 08426950472483 ()
00020300600

  • Heparin anti-Xa IVD, calibrator
Calibration Plasma LMW Heparin
INSTRUMENTATION LABORATORY COMPANY
82 3500 63
In Commercial Distribution

  • 08426950088974 ()
82 3500 63

  • Heparin anti-Xa IVD, calibrator
For calibration of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873530
In Commercial Distribution

  • 00842768017063 ()
OPOB05

  • Heparin anti-Xa IVD, calibrator
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
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