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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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5 Panel DOA Test Dipcard +Adulterant Test StripsOXI/SG/pH
Healgen Scientific Limited Liability Company
HDOA-154A3
In Commercial Distribution

  • 20816490020411 ()
  • 10816490020414 ()
  • 00816490020417 ()
HDOA-154A3

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Inspiration Ventilator System, model 7i Flagship with 17" Display Panel
Event Medical, Ltd.
Inspiration Ventilator System
In Commercial Distribution

  • B079EVM11000103US0 ()
F7300000-7i-F-US

  • General-purpose intensive-care ventilator
Mylar Clad Cartridge Tube for Desk, Panel & Wall Unit 33
W. A. BAUM CO., INC.
2300
In Commercial Distribution

  • 00810010923547 ()
2300

  • Aneroid manual sphygmomanometer
The Dual M5 without Control with two Flat Panel Control, with two Flat Panel Monitors is used with the HarmonyAIR M-Series Lighting System.
STERIS CORPORATION
M-Series Surgical Lighting System
Not in Commercial Distribution

  • 00724995165741 ()
LM03N

  • Operating room light system
  • Medical monitor/light mount
  • Operating room light
Foot Control CAN-Bus
W & H Dentalwerk Bürmoos GmbH
30285002
In Commercial Distribution

  • J021302850020 ()
  • J021302850021 ()


  • Foot-switch, electrical
  • Dental delivery system instrument unit, electric
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
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
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
External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures on the BioFire Joint Infection Panel on the BioFire FilmArray systems.
Mmqci
v.00
In Commercial Distribution

  • 00852720008121 ()
M420

  • Escherichia coli nucleic acid IVD, control
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