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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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O2-Sensor - 04250320600398

No Description
IT Dr. Gambert GmbH
M-16T
In Commercial Distribution

  • 04250320600398 ()
47 01 16

  • Respiratory oxygen sensor

AmplideX Fragile X Dx & Carrier Screen Kit - 00863840000254

No Description
ASURAGEN, INC.
49591
In Commercial Distribution

  • 00863840000254 ()
49591

  • Fragile X syndrome IVD, kit, nucleic acid technique (NAT)

Fragile X Fluorescein-Labelled Probe - 05700571112526

Fragile X Fluorescein-Labelled Probe
AGILENT TECHNOLOGIES, INC.
Y1442
In Commercial Distribution

  • 05700571105368 ()
  • 05700571112526 ()

  • Total Volume: 100 Microliter


  • Fragile X syndrome IVD, probe

Diapharma Factor X Kit - 00867885000200

Chromogenic Factor X
DIAPHARMA GROUP INC.
DPGFX
In Commercial Distribution

  • 00867885000200 ()


  • Coagulation factor X IVD, kit, chromogenic

HemosIL Factor X Deficient Plasma (10 X 1 mL) - 08426950491385

HemosIL Factor X Deficient Plasma (10 X 1 mL)
INSTRUMENTATION LABORATORY COMPANY
00020010000
In Commercial Distribution

  • 08426950491385 ()
  • 18426950491382 ()
00020010000

  • Coagulation factor X IVD, kit, clotting

STA® - Deficient X - 13607450007388

No Description
DIAGNOSTICA STAGO
00738
In Commercial Distribution

  • 13607450007388 ()
  • 03607450007381 ()


  • Coagulation factor X IVD, kit, clotting

TriniCLOT™ Factor X - 15391521420425

No Description
TCOAG IRELAND LIMITED
T1510
In Commercial Distribution

  • 15391521420425 ()
  • 05391521420428 ()


  • Coagulation factor X IVD, kit, clotting

alvin Serrated Elevator - 2.2mm - 00841336102491

No Description
SALVIN DENTAL SPECIALTIES, LLC
DEL-SERR-2
In Commercial Distribution

  • 00841336102491 ()


  • Dental elevator, tooth/root

NA - 00816576020218

CHOCOLATE with BAC / MTM BIPLT (Section I: Chocolate with Bacitracin; Section II: Modified Thayer Martin). For the selective isolation of fastidious bacteria.
HARDY DIAGNOSTICS
J101
Not in Commercial Distribution

  • 00816576020218 ()
  • 00816576021277 ()
J101

  • Haemophillus species agar identification medium IVD

HardyDisk™ - 00816576028320

X Factor, HardyDisk™, Hemin disk to aid in the identification of Haemophilus spp., 50 disks per cartridge, 1 each Contains Hemin (X factor) for the speciation of Haemophilus.
HARDY DIAGNOSTICS
Z7031
In Commercial Distribution

  • 00816576028313 ()
  • 00816576028320 ()
Z7031

  • X factor differentiation disc IVD

X FACTOR - 05032384104635

No Description
OXOID LIMITED
DD0003B
In Commercial Distribution

  • 05032384104635 ()


  • X factor differentiation disc IVD

X FACTOR - 05032384034055

No Description
OXOID LIMITED
DD0003T
In Commercial Distribution

  • 05032384034055 ()


  • X factor differentiation disc IVD

Coagulation Factor X Deficient Plasma - 00630414639598

For the determination of the activity of coagulation factor X in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10873882
In Commercial Distribution

  • 00842768018817 ()
  • 00630414639598 ()
10873882

  • Coagulation factor X IVD, reagent

Factor X Deficient Substrate Plasma - M52551950

No Description
HELENA LABORATORIES CORPORATION
5195
In Commercial Distribution

  • M52551950 ()


  • Coagulation factor X IVD, reagent

Coagulation Factor X Deficient Plasma - 00842768011030

For the determination of the activity of coagulation factor X in human plasma by coagulometric methods
Siemens Healthcare Diagnostics Products GmbH
10446415
In Commercial Distribution

  • 00842768011030 ()
  • 00842768018817 ()
OTXY13

  • Coagulation factor X IVD, reagent

George King Factor X Deficient Plasma - 00815696020993

George King Factor X Deficient Plasma is a fresh frozen citrated human plasma derived from congenital Factor X deficient donors.
GEORGE KING BIO-MEDICAL, INC
1000-5.0
In Commercial Distribution

  • 00815696020993 ()


  • Coagulation factor X IVD, reagent

George King Factor X Deficient Plasma - 00815696020931

George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor X deficient donors.
GEORGE KING BIO-MEDICAL, INC
1000-bulk
In Commercial Distribution

  • 00815696020931 ()


  • Coagulation factor X IVD, reagent

George King Factor X Deficient Plasma - 00815696020788

George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor X deficient donors.
GEORGE KING BIO-MEDICAL, INC
1000 - 250.0
In Commercial Distribution

  • 00815696020788 ()


  • Coagulation factor X IVD, reagent

George King Factor X Deficient Plasma - 00815696020771

George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor X deficient donors.
GEORGE KING BIO-MEDICAL, INC
1000 - 150.0
In Commercial Distribution

  • 00815696020771 ()


  • Coagulation factor X IVD, reagent

George King Factor X Deficient Plasma - 00815696020764

George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor X deficient donors.
GEORGE KING BIO-MEDICAL, INC
1000 - 100.0
In Commercial Distribution

  • 00815696020764 ()


  • Coagulation factor X IVD, reagent
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