Devices

Envoy 500

  • Model / Serial
    all lots
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    Envoy 500 system includes the following product reference numbers and names: || 55345 ENVOY 500 Glucose || 55450 ENVOY 500 URIC ACID REAGENT KIT || 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, || 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, || 55335 ENVOY 500 CREATININE REAGENT KIT || 55301 ENVOY 500 HDL CHOLESTEROL REAGENT || 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT
  • Manufacturer
    ELITech Clinical Systems SAS
  • 1 Event

Manufacturer

ELITech Clinical Systems SAS
  • Manufacturer Address
    ELITech Clinical Systems SAS, Zone lndustrielle, SEES France
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

ENVOY 500 AST Reagent Kit, reference 55255
  • Model / Serial
    Lot 4014, Expiration date 07/2015; Lot 4051, Expiration date 09/2015; Lot 4074, Expiration date 11/2015;
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. || Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry System. || Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain types of liver and heart diseases.
  • Manufacturer
    ELITech Clinical Systems SAS
Device Recall Envoy 500 Serum Control Kit
  • Model / Serial
    Level 1, Lot Number 9141010 and Level 2, Lot Number 9142010.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Envoy 500 Serum Control Kit. || The device is used for monitoring the performance of clinical chemistry methods within the clinical range.
  • Manufacturer
    Vital Diagnostics, Inc.