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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 Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.
AKERS BIOSCIENCES, INC.
4036028
In Commercial Distribution

  • 00708872000011 ()
  • 01708872000011 ()
4036028

  • Platelet factor 4-heparin complex antibody IVD, control
The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Rapid Assay. Included are both confirmed positive and negative control panel members.
AKERS BIOSCIENCES, INC.
4036027
In Commercial Distribution

  • 00708872000004 ()
  • 01708872000004 ()
4036027

  • Platelet factor 4-heparin complex antibody IVD, control
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
No Description
Selux Diagnostics, Inc.
01-80001
In Commercial Distribution

  • 10850031114026 ()
  • 00850031114029 ()


  • Antimicrobial susceptibility analyser IVD
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
Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood.
Home Access Health Corporation
81
In Commercial Distribution

  • M769CHOLESTEROL811 ()


  • Capillary blood collection set, home-use
Cholesterol Panel Test Kit for the quantitative determination of total cholesterol, HDL, LDL, and triglycerides. Results used in the diagnosis and treatment of disorders involving excess cholesterol in the blood.
Home Access Health Corporation
80
In Commercial Distribution

  • M769CHOLESTEROL801 ()


  • Capillary blood collection set, home-use
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)
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