HbA1c

GUDID 03661540215001

ELITECH CLINICAL SYSTEMS SAS

Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry

• Primary Device ID: 03661540215001
• NIH Device Record Key: b7f6c1e4-e1cb-40d8-a8ca-9758ca72e37a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HbA1c
• Version Model Number: HBAC-0240
• 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	03661540215001 [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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