Duns Number:051957769
Device Description: The ReliOn™ Fast A1C Test provides quantitative measurement of the percent of glycated hem The ReliOn™ Fast A1C Test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
Catalog Number
3055
Brand Name
ReliOn™ Fast A1C Test
Version/Model Number
3055
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 27, 2018
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
Product Code
LCP
Product Code Name
Assay, Glycosylated Hemoglobin
Public Device Record Key
f9d905ba-f205-446f-b09b-eb4f137c7a20
Public Version Date
October 14, 2021
Public Version Number
4
DI Record Publish Date
September 01, 2016
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 | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |