BioHermes Glycohemoglobin Test Kit GCA-S22

GUDID 06935784400040

Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 12 Tests/Kit. Intended use: This GluCoA1c glycohemoglobin test kit is intended to be used with the GluCoA1c blood glucose and glycohemoglobin analyzer to quantitatively measure glycohemoglobin (HbA1c) level in whole blood (capillary blood or venous blood). Contents: Code Chip x 1 piece; HbA1c Test Strip x 12 pieces; Sampler x 12 pieces; Buffer Ax 1 bottle; Buffer Bx 1 bottle.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

• Primary Device ID: 06935784400040
• NIH Device Record Key: 45a11a20-5d99-4d88-bb70-c9e5b84ebe44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioHermes Glycohemoglobin Test Kit
• Version Model Number: GLU-A1C S03
• Catalog Number: GCA-S22
• 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: true
• 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	06935784400040 [Primary]
GS1	16935784400047 [Package]; Package: box [8 Units]; In Commercial Distribution
GS1	26935784400044 [Package]; Contains: 16935784400047; Package: box [5 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

On-Brand Devices [BioHermes Glycohemoglobin Test Kit]

• 06935784411176: A1cChek Express Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 25 Tests/Kit . Int
• 06935784400071: Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 12 Tests/Kit . Intended use: This
• 06935784400040: Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 12 Tests/Kit. Intended use: This G
• 06935784400033: Glycohemoglobin Test Kit ( Boronate Affinity Chromatography) 25 Tests/Kit. lntended use: This A