HOME ACCESS A1C TEST

Primary DI
M769A1CPCP841
Brand
HOME ACCESS A1C TEST
Company
Home Access Health Corporation
Model
84
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.
Published
2017-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M769A1CPCP841PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Home blood collection kitA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
848511283
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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M769MAUTEST371URINE COLLECTION KIT372020-09-18
M769MAUTEST391URINE COLLECTION KIT392020-09-19