BioHermes A1cChek Pro Glycohemoglobin Analyzer A1C-M31

GUDID 06935784400026

A1cChek Pro Glycohemoglobin Analysis System is intended for the percent determination of Hemoglobin A1c in human whole blood using boronate affinity chromatography. A1cChek Pro Glycohemoglobin Analyzer is intended for Professional Use Only. For In Vitro Diagnostic Use Only.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

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• Primary Device ID: 06935784400026
• NIH Device Record Key: 213076e3-fa8b-43a4-822d-4bed37d85b9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioHermes A1cChek Pro Glycohemoglobin Analyzer
• Version Model Number: A1C EZ Auto 4 W
• Catalog Number: A1C-M31
• Company DUNS: 528192913
• Company Name: Wuxi Biohermes Bio & Medical Technology Co.,Ltd.
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06935784400026 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-02
• Device Publish Date: 2021-05-25

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