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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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BIOPHEN LMWH Control Low - 03663537008368

No Description
HYPHEN BIOMED
223701
In Commercial Distribution

  • 03663537008368 ()
223701

  • Heparin anti-Xa IVD, control

BIOPHEN UFH Control Plasma - 03663537008290

No Description
HYPHEN BIOMED
223101
In Commercial Distribution

  • 03663537008290 ()
223101

  • Heparin anti-Xa IVD, control

BIOPHEN LMWH Control Plasma - 03663537008283

No Description
HYPHEN BIOMED
223001
In Commercial Distribution

  • 03663537008283 ()
223001

  • Heparin anti-Xa IVD, control

BIOPHEN UFH CONTROL C2 - 03663537007996

No Description
HYPHEN BIOMED
223901
In Commercial Distribution

  • 03663537007996 ()
223901

  • Heparin anti-Xa IVD, control

BIOPHEN LMWH Control C3 - 03663537007989

No Description
HYPHEN BIOMED
223801
In Commercial Distribution

  • 03663537007989 ()
223801

  • Heparin anti-Xa IVD, control

INNOVANCE Heparin LMW Control 1 - 00842768017100

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

INNOVANCE Heparin LMW Control 2 - 00842768017094

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

INNOVANCE Heparin UF Control 2 - 00842768017087

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

INNOVANCE Heparin UF Control 1 - 00842768017070

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 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

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

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

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

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

HemosIL Heparin Calibrators - 08426950472483

HemosIL Heparin Calibrators
INSTRUMENTATION LABORATORY COMPANY
00020300600
In Commercial Distribution

  • 08426950472483 ()
00020300600

  • Heparin anti-Xa IVD, calibrator

Calibration Plasma LMW Heparin - 08426950088974

Calibration Plasma LMW Heparin
INSTRUMENTATION LABORATORY COMPANY
82 3500 63
In Commercial Distribution

  • 08426950088974 ()
82 3500 63

  • Heparin anti-Xa IVD, calibrator

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

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

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

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

ACTICHROME HEPARIN (ANTI-FXA) - 00850201006079

No Description
Biomedica ADI Inc.
832
In Commercial Distribution

  • 00850201006079 ()
832

  • 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

HemosIL Heparin - 08426950042211

HemosIL Heparin
INSTRUMENTATION LABORATORY COMPANY
00020009400
In Commercial Distribution

  • 08426950042211 ()
00020009400

  • Heparin anti-Xa IVD, kit, chromogenic

HemosIL Liquid Anti-Xa - 08426950580324

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

  • 08426950580324 ()
00020302600

  • 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

Coamatic Heparin - 08426950088967

Coamatic Heparin
INSTRUMENTATION LABORATORY COMPANY
82 3393 63
In Commercial Distribution

  • 08426950088967 ()
82 3393 63

  • 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

STA® - Liquid Anti-Xa 8 - 03607450011791

No Description
DIAGNOSTICA STAGO
00322US
In Commercial Distribution

  • 03607450011791 ()


  • Heparin anti-Xa IVD, kit, chromogenic

STA® - Liquid Anti-Xa 4 - 03607450011784

No Description
DIAGNOSTICA STAGO
00311US
In Commercial Distribution

  • 03607450011784 ()


  • Heparin anti-Xa IVD, kit, chromogenic

Stachrom® Heparin - 03607450009064

No Description
DIAGNOSTICA STAGO
00906
In Commercial Distribution

  • 03607450009064 ()


  • Heparin anti-Xa IVD, kit, chromogenic

NA - 10721902843010

CRTG 304-30 HR-ACT HMS 2CHAN 5L INT 18BX
MEDTRONIC, INC.
304-30
In Commercial Distribution

  • 10721902843010 ()
  • 00721902843013 ()


  • 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
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