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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 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)
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
Immunoassay for the detection of the following drug substance(s) in human urine: COC / M-AMP / OPI / THC
RAPID DIAGNOSTICS INC
07RD-7110-22
In Commercial Distribution

  • 00817830022818 ()

  • Length: 75 Millimeter
07RD-7110-22

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
423742
In Commercial Distribution

  • 00815381020529 ()


  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 6 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0125
Not in Commercial Distribution

  • 00815381020079 ()
RFIT-ASY-0125

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
IVD reagent kit containing 30 tests.
BIOFIRE DIAGNOSTICS, LLC
RFIT-ASY-0124
Not in Commercial Distribution

  • 00815381020062 ()
RFIT-ASY-0124

  • Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Aktina Corp.
11-202
In Commercial Distribution

  • B365112020 ()


  • Radiological whole-body positioner
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