BioHermes A1cChek Express Glycohemoglobin Analyzer A1C-M41

GUDID 06935784411077

A1cChek Express Glycohemoglobin analyzer is for use with the A1cChek Express Glycohemoglobin Test Kit to quantitatively measure the HbA1c in human capillary blood or venous blood.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Glycated haemoglobin (HbA1c) monitoring system IVD, point-of-care

• Primary Device ID: 06935784411077
• NIH Device Record Key: 999d3f3f-47d4-4405-9e1f-c9ede29d5718
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioHermes A1cChek Express Glycohemoglobin Analyzer
• Version Model Number: A1C-EXP M12
• Catalog Number: A1C-M41
• 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	06935784411077 [Primary]
GS1	16935784411074 [Package]; Package: box [4 Units]; In Commercial Distribution

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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