BioHermes Glycohemoglobin Quality Control A1C-C12

GUDID 06935784400088

Glycohemoglobin Quality Control, (10x50uL)/Kit. Intended use: The Glycohemoglobin Quality Control is intended to be used as an assayed quality control material to monitor the precision of testing procedures for glycohemoglobin analysis systems (glycohemoglobin analyzers and test kits) with the methodology of boronate affinity chromatography, manufactured by Wuxi BioHermes Bio & Medical Technology Co.,Ltd.. Contents: Level 1: 5 vials x 50uL; Level 2: 5 vials x 50uL; Package Insert×1.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Glycated haemoglobin (HbA1c) IVD, control

• Primary Device ID: 06935784400088
• NIH Device Record Key: c1b7f298-8a80-4e27-ae1c-c12f92735fe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioHermes Glycohemoglobin Quality Control
• Version Model Number: A1C-GE C01
• Catalog Number: A1C-C12
• 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: false
• 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	06935784400088 [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: 2022-09-05
• Device Publish Date: 2022-08-26

On-Brand Devices [BioHermes Glycohemoglobin Quality Control]

• 06935784420062: Glycohemoglobin Quality Control, (10x50uL)/Kit. Intended use: The Glycohemoglobin Quality Con
• 06935784400088: Glycohemoglobin Quality Control, (10x50uL)/Kit. Intended use: The Glycohemoglobin Quality Con