BioHermes Glycohemoglobin Test Kit A1C-S22

GUDID 06935784400033

Glycohemoglobin Test Kit ( Boronate Affinity Chromatography) 25 Tests/Kit. lntended use: This A1C EZ2.0 Glyconemogoin Test Kit is intended to be used with the A1CEZ 2.0Glyconemogloin Arnalyzer to quaniativly measue hemoglobinA1c(HbA1c) level in whole blood (capilary blood).This test ki i for self-testinguse, as an aid to monitor the effectiveness of diabetes control. Contents: Code Chip x 1 piece; HbA1c Test Strip x 25 pieces; Sampler x 25 pieces;Buffer Ax 1 bottle;Bulffer Bx 1 bottle.

Wuxi Biohermes Bio & Medical Technology Co.,Ltd.

Glycated haemoglobin (HbA1c) IVD, kit, liquid chromatography

• Primary Device ID: 06935784400033
• NIH Device Record Key: 5dff699b-7ff3-4117-a851-1fd50d787cb3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioHermes Glycohemoglobin Test Kit
• Version Model Number: A1C EZ 2.0
• Catalog Number: A1C-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	06935784400033 [Primary]
GS1	16935784400030 [Package]; Package: box [8 Units]; In Commercial Distribution
GS1	26935784400037 [Package]; Contains: 16935784400030; 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