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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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FILMARRAY NGDS Warrior Panel - CA - IVD reagent kit containing 30 tests (Health Canada licensed version)
BIOFIRE DEFENSE, LLC
DFA2-ASY-0012
In Commercial Distribution

  • 00851458005266 ()
DFA2-ASY-0012

  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
BioFire® Global Fever Panel - IVD reagent kit containing 6 tests
BIOFIRE DEFENSE, LLC
DFA2-ASY-0004
In Commercial Distribution

  • 00851458005242 ()
DFA2-ASY-0004

  • Multiple-type tropical pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests.
BIOFIRE DEFENSE, LLC
NGDS-ASY-0007
In Commercial Distribution

  • 00851458005136 ()
NGDS-ASY-0007

  • Multiple-type biothreat/febrile infection-associated pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
An extension panel for oversized legs that aids in the extension of the AeroWrap which wraps around the leg and provides compression. The device is intended for use in the home or a clinical setting for oversized legs. This is a single-use device.
SUN SCIENTIFIC, INC.
VU6354
In Commercial Distribution

  • 00850051939299 ()
AW-EXT-LB

  • Sequential venous compression system
An extension panel for oversized legs that aids in the extension of the AeroWrap which wraps around the leg and provides compression. The device is intended for use in the home or a clinical setting for oversized legs. This is a single-use device.
SUN SCIENTIFIC, INC.
VU6154
In Commercial Distribution

  • 00850051939282 ()
AW-EXT-SB

  • Sequential venous compression system
9 Panel Drug Test Cup AMP/BAR/BZO/COC/MDMA/MTD/OPI/PCP/PPX
UCP BIOSCIENCES, INC.
U-CUP-794
In Commercial Distribution

  • 20817038022270 ()
  • 10817038022273 ()
  • 00817038022276 ()
U-CUP-794

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
10 Panel Drug Test Cup AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC
UCP BIOSCIENCES, INC.
U-CUP-13104
In Commercial Distribution

  • 00817038022252 ()
  • 10817038022259 ()
  • 20817038022256 ()
U-CUP-13104

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
6 Panel Drug Test Cup AMP/BUP/BZO/COC/MOP/OXY with Adulteration strip (OX/S.G./pH)
UCP BIOSCIENCES, INC.
U-CUP-2064-3AD
In Commercial Distribution

  • 20817038022072 ()
  • 10817038022075 ()
  • 00817038022078 ()
U-CUP-2064-3AD

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
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 NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection.
Luminex Molecular Diagnostics, Inc
I051C0447
In Commercial Distribution

  • 00840487100417 ()
I051C0447

  • Multiple-genus respiratory virus nucleic acid IVD, kit, nucleic acid technique (NAT)
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