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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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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.
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
5 x 5 cm Fenestrated Plus Biologic Wound Matrix
REPRISE BIOMEDICAL, INC.
BLM-200-03-0505
In Commercial Distribution

  • 00857072005231 ()


  • Animal-derived wound matrix dressing
#5/6 Mini 5 Rigid Curette, EE2 Resin 8
HU-FRIEDY MFG. CO., LLC
SAS5/6RC8E2
In Commercial Distribution

  • 10889950103750 ()


  • Periodontal curette
#5/6 Mini 5 Gracey Curette,EE2 Resin 8
HU-FRIEDY MFG. CO., LLC
SAS5/6C8E2
In Commercial Distribution

  • 10889950103736 ()


  • Periodontal curette
QUANTUM Fixed Insert Implant Size 5 Right 5 mm
IN2BONES
M50 SU155
In Commercial Distribution

  • 03701337602260 ()

  • Length: 40.57 Millimeter
  • Length: 34 Millimeter
M50 SU155

  • Fixed-bearing total ankle prosthesis
QUANTUM Fixed Insert Implant Size 5 Left 5 mm
IN2BONES
M50 SU255
In Commercial Distribution

  • 03701337602185 ()

  • Length: 40.57 Millimeter
  • Length: 34 Millimeter
M50 SU255

  • Fixed-bearing total ankle prosthesis
5 Inch Sof-Pad F/5 Inch Table Side Extension
SKYTRON LLC
3-060-05-5S
In Commercial Distribution

  • 10841736122126 ()
3-060-05-5S

  • Operating table patient pressure distribution pad, reusable
5' HOSE ASMBLY US VAC OF-DC COND 5/16"
OHIO MEDICAL, LLC
HS-05UV-OFDCC5
In Commercial Distribution

  • 00628101613853 ()
HS-05UV-OFDCC5

  • General-gas low pressure tubing, reusable
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