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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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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

BD BBL™ Taxo™ VX - 00382902317319

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™ X - 00382902317296

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™ V - 00382902317272

BD BBL™ Taxo™ Differentiation Discs V
BECTON, DICKINSON AND COMPANY
231727
In Commercial Distribution

  • 00382902317272 ()
231727

  • X/V factor differentiation disc IVD

STA® - Hepanorm® H - 03607450006841

No Description
DIAGNOSTICA STAGO
00684
In Commercial Distribution

  • 03607450006841 ()


  • Heparin anti-Xa IVD, calibrator

STA® - Hepanorm® HBPM/LMWH - 03607450006810

No Description
DIAGNOSTICA STAGO
00681
In Commercial Distribution

  • 03607450006810 ()


  • Heparin anti-Xa IVD, calibrator

STA® - Multi Hep Calibrator - 03607450003482

No Description
DIAGNOSTICA STAGO
00348
In Commercial Distribution

  • 03607450003482 ()


  • Heparin anti-Xa IVD, calibrator

HemosIL Liquid Anti-Xa - 08426950580324

HemosIL Liquid Anti-Xa
INSTRUMENTATION LABORATORY COMPANY
00020302600
In Commercial Distribution

  • 08426950580324 ()
00020302600

  • Heparin anti-Xa IVD, kit, chromogenic

Coamatic Heparin - 08426950088967

Coamatic Heparin
INSTRUMENTATION LABORATORY COMPANY
82 3393 63
In Commercial Distribution

  • 08426950088967 ()
82 3393 63

  • Heparin anti-Xa IVD, kit, chromogenic

HemosIL Liquid Heparin - 08426950472476

HemosIL Liquid Heparin
INSTRUMENTATION LABORATORY COMPANY
00020300100
Not in Commercial Distribution

  • 08426950472476 ()
00020300100

  • Heparin anti-Xa IVD, kit, chromogenic

Coatest Heparin - 08426950088196

Coatest Heparin
INSTRUMENTATION LABORATORY COMPANY
25 5539 63
In Commercial Distribution

  • 08426950088196 ()
25 5539 63

  • Heparin anti-Xa IVD, kit, chromogenic

HemosIL Heparin - 08426950042211

HemosIL Heparin
INSTRUMENTATION LABORATORY COMPANY
00020009400
In Commercial Distribution

  • 08426950042211 ()
00020009400

  • Heparin anti-Xa IVD, kit, chromogenic

BIOPHEN HEPARIN 6 - 03663537008191

No Description
HYPHEN BIOMED
221006
In Commercial Distribution

  • 03663537008191 ()
221006

  • Heparin anti-Xa IVD, kit, chromogenic

BIOPHEN HEPARIN 3 - 03663537008184

No Description
HYPHEN BIOMED
221003
In Commercial Distribution

  • 03663537008184 ()
221003

  • Heparin anti-Xa IVD, kit, chromogenic

ACTICHROME HEPARIN (ANTI-FXA) - 00850201006079

No Description
Biomedica ADI Inc.
832
In Commercial Distribution

  • 00850201006079 ()
832

  • Heparin anti-Xa IVD, kit, chromogenic

INNOVANCE Heparin - 00630414639864

For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)
Siemens Healthcare Diagnostics Products GmbH
10873930
In Commercial Distribution

  • 00630414639864 ()
10873930

  • Heparin anti-Xa IVD, kit, chromogenic

HR HTC - 10885074117314

CARTRIDGE 402-07 HR HTC BXD 11L 20BX
MEDTRONIC, INC.
402-07
Not in Commercial Distribution

  • 10885074117314 ()
  • 00885074117317 ()


  • Heparin anti-Xa IVD, kit, chromogenic

INNOVANCE Heparin - 00842768017438

For the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)
Siemens Healthcare Diagnostics Products GmbH
10873535
In Commercial Distribution

  • 00842768017438 ()
OPOA05

  • Heparin anti-Xa IVD, kit, chromogenic

Berichrom® Heparin - 00842768012945

Determination of heparin activity in plasma and for the monitoring of heparin therapy
Siemens Healthcare Diagnostics Products GmbH
10446620
Not in Commercial Distribution

  • 00842768012945 ()
OWLD11

  • Heparin anti-Xa IVD, kit, chromogenic

NA - 20763000441450

CARTRIDGE 402-07 HR HTC BXD 11L 20BX
MEDTRONIC, INC.
402-07
In Commercial Distribution

  • 00763000441456 ()
  • 20763000441450 ()


  • Heparin anti-Xa IVD, kit, chromogenic
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