HOME ACCESS A1C TEST

GUDID M769A1C821

The Home Access A1c Test kit is an in vitro test for the quantitative measurement of Hemoglobin A1c using capillary blood. Measurements obtained through this test kit can be used for monitoring the long-term control of blood sugar (glucose) in people with diabetes.

Home Access Health Corporation

Home blood collection kit

• Primary Device ID: M769A1C821
• NIH Device Record Key: e5278838-8a2f-4863-abf1-44aad74ac1f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOME ACCESS A1C TEST
• Version Model Number: 82
• Company DUNS: 848511283
• Company Name: Home Access Health Corporation
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M769A1C821 [Primary]

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-07-07
• Device Publish Date: 2016-09-09

On-Brand Devices [HOME ACCESS A1C TEST]

• M769A1CPCP841: The Home Access A1c Test kit is an in vitro test for the quantitative measurement of Hemoglobin
• M769A1C821: The Home Access A1c Test kit is an in vitro test for the quantitative measurement of Hemoglobin