ISE DILUENT

GUDID 03661540215506

ELITECH CLINICAL SYSTEMS SAS

Buffered sample diluent IVD

• Primary Device ID: 03661540215506
• NIH Device Record Key: 585db029-39b2-4032-a037-5bc1f49f77a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ISE DILUENT
• Version Model Number: ISDI-0250
• 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	03661540215506 [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: 2023-06-02
• 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