Duns Number:051957769
Device Description: The ReliOn A1C Self Test System provides a quantitative measurement of the percent of glyc The ReliOn A1C Self Test System provides a quantitative measurement of the percent of glycated hemoglobin levels in capillary (fingerstick) blood samples. The test is for home use to monitor glycemic control in people with diabetes.
Catalog Number
3055
Brand Name
ReliOn™ 2CT A1C Meter
Version/Model Number
3055
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090413,K090413,K090413
Product Code
LCP
Product Code Name
Assay, Glycosylated Hemoglobin
Public Device Record Key
6e5c0a13-7d3e-4899-80f4-7283f455f5c9
Public Version Date
October 14, 2021
Public Version Number
2
DI Record Publish Date
March 30, 2021
Package DI Number
10681131403259
Quantity per Package
24
Contains DI Package
00681131403252
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |