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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

George King Factor X Deficient Plasma - 00815696020757

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 - 50.0
In Commercial Distribution

  • 00815696020757 ()


  • Coagulation factor X IVD, reagent

George King Factor X Deficient Plasma - 00815696020061

George King Factor X Deficient Plasma is fresh frozen citrated human plasma derived from congenital Factor X deficient donors.
GEORGE KING BIO-MEDICAL, INC
1000-1.0
In Commercial Distribution

  • 00815696020061 ()


  • Coagulation factor X IVD, reagent

INNOVANCE Heparin LMW Control 1 - 00630414639956

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

INNOVANCE Heparin UF Control 1 - 00630414639949

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

INNOVANCE Heparin LMW Control 2 - 00630414639857

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

INNOVANCE Heparin UF Control 2 - 00630414639840

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

Validate - 00859110005111

Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activity on automated instruments
Lgc Clinical Diagnostics, Inc.
903se
In Commercial Distribution

  • 00859110005111 ()

  • 1 test
903se

  • Heparin anti-Xa IVD, control

Validate - 00859110005104

Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments
Lgc Clinical Diagnostics, Inc.
903st
In Commercial Distribution

  • 00859110005104 ()

  • 1 test
903st

  • Heparin anti-Xa IVD, control

Validate - 00859110005098

Validate Heparin is intended for the quantitative determination of Calibration Verification/Linearity of the heparin anti-Xa activityon automated instruments
Lgc Clinical Diagnostics, Inc.
903il
In Commercial Distribution

  • 00859110005098 ()

  • 1 test
903il

  • Heparin anti-Xa IVD, control

BIOPHEN LMWH Control C4 - 03663537043550

No Description
HYPHEN BIOMED
224201
In Commercial Distribution

  • 03663537043550 ()
224201

  • Heparin anti-Xa IVD, control

BIOPHEN LMWH CONTROL LOW CII - 03663537043512

No Description
HYPHEN BIOMED
224401
In Commercial Distribution

  • 03663537043512 ()
224401

  • Heparin anti-Xa IVD, control

BIOPHEN LMWH CONTROL LOW CI - 03663537043505

No Description
HYPHEN BIOMED
224301
In Commercial Distribution

  • 03663537043505 ()
224301

  • Heparin anti-Xa IVD, control

BIOPHEN UFH Control C1 - 03663537042904

No Description
HYPHEN BIOMED
224101
In Commercial Distribution

  • 03663537042904 ()
224101

  • Heparin anti-Xa IVD, control

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

HemosIL UF Heparin Controls - 08426950478683

HemosIL UF Heparin Controls
INSTRUMENTATION LABORATORY COMPANY
00020300300
In Commercial Distribution

  • 08426950478683 ()
  • 18426950478680 ()
00020300300

  • Heparin anti-Xa IVD, control

HemosIL LMW Heparin Controls - 08426950472490

HemosIL LMW Heparin Controls
INSTRUMENTATION LABORATORY COMPANY
00020300200
In Commercial Distribution

  • 08426950472490 ()
00020300200

  • Heparin anti-Xa IVD, control

Control Plasma LMW Heparin - 08426950083597

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

  • 08426950083597 ()
82 3492 63

  • Heparin anti-Xa IVD, control

STA® - Quality HBPM/LMWH - 03607450006865

No Description
DIAGNOSTICA STAGO
00686
In Commercial Distribution

  • 03607450006865 ()


  • Heparin anti-Xa IVD, control

STA® - Heparin Control - 03607450006834

No Description
DIAGNOSTICA STAGO
00683
In Commercial Distribution

  • 03607450006834 ()


  • Heparin anti-Xa IVD, control

STA® - HBPM/LMWH Control - 03607450006827

No Description
DIAGNOSTICA STAGO
00682
In Commercial Distribution

  • 03607450006827 ()


  • Heparin anti-Xa IVD, control

STA® - Quality HNF/UFH - 03607450003819

No Description
DIAGNOSTICA STAGO
00381
In Commercial Distribution

  • 03607450003819 ()


  • 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
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