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
OXOID LIMITED
DD0005T
In Commercial Distribution

  • 05032384034109 ()


  • X/V factor differentiation disc IVD
No Description
OXOID LIMITED
DD0005B
In Commercial Distribution

  • 05032384105014 ()


  • 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
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
For calibration of the INNOVANCE® Heparin assay
Siemens Healthcare Diagnostics Products GmbH
10873530
In Commercial Distribution

  • 00842768017063 ()
OPOB05

  • 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
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
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
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
No Description
DIAGNOSTICA STAGO
00348
In Commercial Distribution

  • 03607450003482 ()


  • 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
No Description
Biomedica ADI Inc.
832
In Commercial Distribution

  • 00850201006079 ()
832

  • Heparin anti-Xa IVD, kit, chromogenic
CARTRIDGE 402-07 HR HTC BXD 11L 20BX
MEDTRONIC, INC.
402-07
Not in Commercial Distribution

  • 10885074117314 ()
  • 00885074117317 ()


  • Heparin anti-Xa IVD, kit, chromogenic
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
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
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
No Description
HYPHEN BIOMED
221006
In Commercial Distribution

  • 03663537008191 ()
221006

  • Heparin anti-Xa IVD, kit, chromogenic
No Description
HYPHEN BIOMED
221003
In Commercial Distribution

  • 03663537008184 ()
221003

  • Heparin anti-Xa IVD, kit, chromogenic
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
HemosIL Liquid Anti-Xa
INSTRUMENTATION LABORATORY COMPANY
00020302600
In Commercial Distribution

  • 08426950580324 ()
00020302600

  • Heparin anti-Xa IVD, kit, chromogenic
HemosIL Liquid Heparin
INSTRUMENTATION LABORATORY COMPANY
00020300100
Not in Commercial Distribution

  • 08426950472476 ()
00020300100

  • Heparin anti-Xa IVD, kit, chromogenic
Coamatic Heparin
INSTRUMENTATION LABORATORY COMPANY
82 3393 63
In Commercial Distribution

  • 08426950088967 ()
82 3393 63

  • Heparin anti-Xa IVD, kit, chromogenic
Coatest Heparin
INSTRUMENTATION LABORATORY COMPANY
25 5539 63
In Commercial Distribution

  • 08426950088196 ()
25 5539 63

  • Heparin anti-Xa IVD, kit, chromogenic
HemosIL Heparin
INSTRUMENTATION LABORATORY COMPANY
00020009400
In Commercial Distribution

  • 08426950042211 ()
00020009400

  • Heparin anti-Xa IVD, kit, chromogenic
No Description
DIAGNOSTICA STAGO
00322US
In Commercial Distribution

  • 03607450011791 ()


  • Heparin anti-Xa IVD, kit, chromogenic
No Description
DIAGNOSTICA STAGO
00311US
In Commercial Distribution

  • 03607450011784 ()


  • Heparin anti-Xa IVD, kit, chromogenic
No Description
DIAGNOSTICA STAGO
00906
In Commercial Distribution

  • 03607450009064 ()


  • Heparin anti-Xa IVD, kit, chromogenic
CARTRIDGE 402-03 ACT HR 13 LAN
MEDTRONIC, INC.
402-03
In Commercial Distribution

  • 00763000433840 ()
  • 20763000433844 ()


  • Heparin anti-Xa IVD, kit, chromogenic
CARTRIDGE 402-02 ACT RACT 13 LAN
MEDTRONIC, INC.
402-02
In Commercial Distribution

  • 00763000433833 ()
  • 20763000433837 ()


  • Heparin anti-Xa IVD, kit, chromogenic
CARTRIDGE 402-01 ACT LR 13 LAN
MEDTRONIC, INC.
402-01
In Commercial Distribution

  • 00763000433819 ()
  • 20763000433813 ()


  • Heparin anti-Xa IVD, kit, chromogenic
CARTRIDGE 402-07 HR HTC BXD 11L 20BX
MEDTRONIC, INC.
402-07
In Commercial Distribution

  • 00763000441456 ()
  • 20763000441450 ()


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-20POR PORC HDR 5L INT 9BX
MEDTRONIC, INC.
304-20POR
In Commercial Distribution

  • 00643169730151 ()
  • 20643169730155 ()


  • Heparin anti-Xa IVD, kit, chromogenic
CARTRIDGE 402-07 HR HTC BXD 11L 20BX
MEDTRONIC, INC.
402-07
In Commercial Distribution

  • 20643169713264 ()
  • 00643169713260 ()


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-30 HR-ACT HMS 2CHAN 5L INT 18BX
MEDTRONIC, INC.
304-30
In Commercial Distribution

  • 00643169713253 ()
  • 20643169713257 ()


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-11POR PORC HMS BLK 5L INT 9PK
MEDTRONIC, INC.
304-11POR
In Commercial Distribution

  • 00643169713246 ()
  • 20643169713240 ()

  • Range: 3.5-6.0MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-10POR PORC HMS PRP 5L INT 9PK
MEDTRONIC, INC.
304-10POR
In Commercial Distribution

  • 00643169713239 ()
  • 20643169713233 ()

  • Range: 4.5-6.0MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-09POR PORC HMS WHT 5L INT 9PK
MEDTRONIC, INC.
304-09POR
In Commercial Distribution

  • 00643169713222 ()
  • 20643169713226 ()

  • Range: 2.5-5.0MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-08POR PORC HMS GLD 5L INT 9PK
MEDTRONIC, INC.
304-08POR
In Commercial Distribution

  • 00643169713215 ()
  • 20643169713219 ()

  • Range: 1.5-4.0MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-07POR PORC HMS ORG 5L INT 9PK
MEDTRONIC, INC.
304-07POR
In Commercial Distribution

  • 00643169713208 ()
  • 20643169713202 ()

  • Range: 0.0-2.5MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-06POR PORC HMS GRN 5L INT 9PK
MEDTRONIC, INC.
304-06POR
In Commercial Distribution

  • 00643169713192 ()
  • 20643169713196 ()

  • Range: 3.5-5.0MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-05POR PORC HMS BLU 5L INT 9PK
MEDTRONIC, INC.
304-05POR
In Commercial Distribution

  • 00643169713185 ()
  • 20643169713189 ()

  • Range: 2.5-4.0MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-04POR PORC HMS SIL 5L INT 9PK
MEDTRONIC, INC.
304-04POR
In Commercial Distribution

  • 00643169713178 ()
  • 20643169713172 ()

  • Range: 2.0-3.5MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-03POR PORCINE HMS TAN 5L 9PK
MEDTRONIC, INC.
304-03POR
In Commercial Distribution

  • 00643169713161 ()
  • 20643169713165 ()

  • Range: 1.5-3.0MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic
CRTG 304-02POR PORCINE HMS YEL 5L 9PK
MEDTRONIC, INC.
304-02POR
In Commercial Distribution

  • 00643169713154 ()
  • 20643169713158 ()

  • Range: 0.0-1.5MG/KG


  • Heparin anti-Xa IVD, kit, chromogenic
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