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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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Initial IQ,LP ONE,Enamel Effect Shade V,L-V,4g
Gc America Inc.
876466
In Commercial Distribution

  • J0228764661 ()
876466

  • Dental appliance fabrication material, ceramic
Initial IQ,LP ONE,Enamel Effect Shade V,L-V,4g
Gc America Inc.
876466
In Commercial Distribution

  • 15400556700379 ()
876466

  • Dental appliance fabrication material, ceramic
CUSTOM PACK BB11T20R 6PK L I V A C C
MEDTRONIC, INC.
BB11T20R
In Commercial Distribution

  • 20763000590646 ()
  • 00763000590635 ()


  • Cardiopulmonary bypass system blood tubing set
Spacelabs Compatible Disposable ECG Leadwire, 5 lead V lead, Clip
APK Technology Co.,Ltd.
A0006D05-003
In Commercial Distribution

  • 16946725597986 ()
  • 06946725545218 ()


  • Electrocardiographic lead set, single-use
KleenSpec Illumination System (with cord)—4.7 V Halogen Light Handle with on/off switch and transformer, 110-130 V, 60 Hz for North America
WELCH ALLYN, INC.
901070
In Commercial Distribution

  • 00732094236460 ()
78900

  • General-purpose light source
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
30-001-001
Not in Commercial Distribution

  • 00857573006348 ()


  • Multiple coagulation factor IVD, kit, clotting
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
NANOSPHERE, INC.
20-006-001
Not in Commercial Distribution

  • 00857573006027 ()


  • Multiple coagulation factor IVD, kit, clotting
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
LUMINEX CORPORATION
30-001-001
Not in Commercial Distribution

30-001-001

  • Multiple coagulation factor IVD, kit, clotting
The Verigene® Hypercoagulation Panel Nucleic Acid Test contains the Verigene® F5 Nucleic Acid Test, the Verigene® F2 Nucleic Acid Test and the Verigene® MTHFR Nucleic Acid Test. The Verigene® F5 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 1691; also known as Factor V Leiden) of the human Factor V gene (F5; Coagulation Factor V gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® F2 Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (G to A at position 20210) of the human Factor II gene (F2; prothrombin gene) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples. The Verigene® MTHFR Nucleic Acid Test is an in vitro diagnostic for the detection and genotyping of a single point mutation (C to T at position 677) of the human 5,10 methylenetetrahydrofolate reductase gene (MTHFR) in patients with suspected thrombophilia, from isolated genomic DNA obtained from whole blood samples.
LUMINEX CORPORATION
20-006-001
Not in Commercial Distribution

20-006-001

  • Multiple coagulation factor IVD, kit, clotting
Bretahing Circuit, Adult, 72", GSE w/Port, parallel WYE, HEPA filter w/o port, B/V Filter, 40" Tube Extension w/ B/V Filter
WESTMED, INC.
61272ARW
In Commercial Distribution

  • 10709078009935 ()
  • 00709078009938 ()


  • Anaesthesia breathing circuit, single-use
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