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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.
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
Circuit, Disposable, 15mm, Non Heated, Dual Limb, B/V Filters
WESTMED, INC.
8303
In Commercial Distribution

  • 10709078008860 ()
  • 00709078008863 ()
  • 00709078011924 ()


  • Anaesthesia breathing circuit, single-use
NERA PRO, KIT 312 WL DIR 90 L V BE
Oticon A/S
131908
In Commercial Distribution

  • 05707131259165 ()


  • Air-conduction hearing aid, in-the-ear
NERA PRO, KIT 312 WL DIR 90 R V BE
Oticon A/S
131907
In Commercial Distribution

  • 05707131259158 ()


  • Air-conduction hearing aid, in-the-ear
NERA PRO, KIT 312 WL DIR 85 L V BE
Oticon A/S
131896
In Commercial Distribution

  • 05707131259103 ()


  • Air-conduction hearing aid, in-the-ear
NERA PRO, KIT 312 WL DIR 85 R V BE
Oticon A/S
131895
In Commercial Distribution

  • 05707131259097 ()


  • Air-conduction hearing aid, in-the-ear
RIA2, KIT 312 WL DIR 90 PB L V BE
Oticon A/S
147227
In Commercial Distribution

  • 05707131291578 ()


  • Air-conduction hearing aid, in-the-ear
RIA2, KIT 312 WL DIR 85 PB L V BE
Oticon A/S
147226
In Commercial Distribution

  • 05707131291561 ()


  • Air-conduction hearing aid, in-the-ear
RIA2, KIT 312 WL DIR 90 PB R V BE
Oticon A/S
147225
In Commercial Distribution

  • 05707131291554 ()


  • Air-conduction hearing aid, in-the-ear
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