Duns Number:848511283
Device Description: The Home Access A1c Test kit is an in vitro test for the quantitative measurement of Hemog 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.
Catalog Number
-
Brand Name
HOME ACCESS A1C TEST
Version/Model Number
84
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
b4de4180-243d-454a-a0b7-bed5d42c231d
Public Version Date
November 23, 2021
Public Version Number
4
DI Record Publish Date
October 06, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 2 |