HOME ACCESS A1C TEST

Basic Information

• Brand Name: HOME ACCESS A1C TEST
• Primary DI: M769A1CPCP841
• Version / Model: 84
• Company Name: Home Access Health Corporation
• Labeler DUNS: 848511283
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-06
• Public Version: 4
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: b4de4180-243d-454a-a0b7-bed5d42c231d

Device Description

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. Contains space for Patient PCP information.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
38092	Capillary blood collection kit, home-use	A collection of devices and materials available for use by a patient/layperson outside a clinical setting to collect and mail a capillary blood sample to a clinical laboratory for diagnostic testing or screening purposes. The kit includes a lancet, a blood collection strip, dry blood collection card/filter paper card, and other items (e.g., alcohol prep pad, disposable lancet, gauze pad, bandage strip, and a container with a requisition form, for mailing to the laboratory). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M769A1CPCP841	HIBCC