ELICAL 2

GUDID 03661540213809

ELITECH CLINICAL SYSTEMS SAS

Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator

• Primary Device ID: 03661540213809
• NIH Device Record Key: 11a21ea0-9182-4af6-998a-97c1a49c5be1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELICAL 2
• Version Model Number: CALI-0580
• 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	03661540213809 [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: 2020-12-21
• Device Publish Date: 2016-09-24

Devices Manufactured by ELITECH CLINICAL SYSTEMS SAS

• 03661540200908 - ENVOY 500 AMYLASE REAGENT KIT: 2023-07-06
• 03661540201004 - ENVOY 500 AST REAGENT KIT: 2023-07-06
• 03661540201202 - ENVOY 500 DIRECT BILIRUBIN REAGENT KIT: 2023-07-06
• 03661540201301 - ENVOY 500 TOTAL BILIRUBIN REAGENT KIT: 2023-07-06
• 03661540201400 - ENVOY 500 CALCIUM REAGENT KIT: 2023-07-06
• 03661540201608 - ENVOY 500 CHOLESTEROL REAGENT KIT: 2023-07-06
• 03661540201707 - ENVOY 500 CK REAGENT KIT: 2023-07-06
• 03661540202001 - ENVOY 500 IRON REAGENT KIT: 2023-07-06