SEARCH RESULTS FOR: (*Sandwhich Panel Machine*)(8535 results)

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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 - 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)
In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of gastrointestinal pathogens.
APPLIED BIOCODE, INC.
1
In Commercial Distribution

  • 00851034007011 ()


  • Multiple-type gastrointestinal pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
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 NeoCoil Patient Communication and Entertainment (PCE) System is intended to provide audio entertainment and facilitate communications between the patient and the operator in a Magnetic Resonance Imaging (MRI) scanner environment. The PCE System is intended to be used by healthcare professionals.
NEOCOIL, LLC
41
In Commercial Distribution

  • 00856181003411 ()


  • Headphones
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
No Description
Selux Diagnostics, Inc.
01-80001
In Commercial Distribution

  • 10850031114026 ()
  • 00850031114029 ()


  • Antimicrobial susceptibility analyser IVD
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
CardioChek® Plus Home Lipid Panel Self-Test test strips are in vitro diagnostic devices used to measure total cholesterol, HDL cholesterol, and triglycerides levels in human whole blood from the fingertip, as well as providing a calculated value for LDL levels. These test strips must be used in conjunction with a CardioChek Plus Home Self-Test analyzer.
POLYMER TECHNOLOGY SYSTEMS, INC.
REF 4753
In Commercial Distribution

  • 10381934753017 ()
  • 00381934753010 ()
REF 4753

  • Multiple lipid analyte IVD, kit, spectrophotometry
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