EON 300 CHOLESTEROL REAGENT

GUDID 03661540200496

ELITECH CLINICAL SYSTEMS SAS

Total cholesterol lipid IVD, kit, enzyme spectrophotometry

• Primary Device ID: 03661540200496
• NIH Device Record Key: 80b0c8ef-cb72-4ca7-bcc7-f2f564641717
• Commercial Distribution Discontinuation: 2020-09-17
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EON 300 CHOLESTEROL REAGENT
• Version Model Number: 79295
• Company DUNS: 267732378
• Company Name: ELITECH CLINICAL SYSTEMS SAS
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03661540200496 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-05-26
• Device Publish Date: 2016-09-24

Devices Manufactured by ELITECH CLINICAL SYSTEMS SAS

• 03661540200809 - ENVOY 500 ALT REAGENT KIT: 2024-09-16
• 03661540201905 - ENVOY 500 CREATININE REAGENT KIT: 2024-09-16
• 03661540202506 - ENVOY 500 ISE BASELINE SOLUTION KIT: 2024-09-16
• 03661540202605 - ENVOY 500 ISE CALIBRATOR KIT: 2024-09-16
• 03661540202803 - ENVOY 500 ISE REFERENCE SOLUTION KIT: 2024-09-16
• 03661540202902 - ENVOY 500 LDL CALIBRATOR KIT: 2024-09-16
• 03661540203602 - ENVOY 500 TOTAL PROTEIN REAGENT KIT: 2024-09-16
• 03661540203800 - ENVOY 500 BUN REAGENT KIT: 2024-09-16