HbA1c CONTROL L+ H

GUDID 03661540214905

ELITECH CLINICAL SYSTEMS SAS

Glycated haemoglobin (HbA1c) IVD, control

• Primary Device ID: 03661540214905
• NIH Device Record Key: e4350539-f5b5-4a2e-89cf-fb79092f50b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HbA1c CONTROL L+ H
• Version Model Number: HBAC-0049
• 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	03661540214905 [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: 2024-09-16
• Device Publish Date: 2016-09-24

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• 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
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• 03661540203602 - ENVOY 500 TOTAL PROTEIN REAGENT KIT: 2024-09-16
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