Duns Number:051957769
Device Description: ReliOn Confirm/Micro Control contains a known amount of glucose that reacts with the test ReliOn Confirm/Micro Control contains a known amount of glucose that reacts with the test strips and is used to check if the meter and test strips are working correctly. Compare the control solution test result with the range printed on the test strip bottle.
Catalog Number
-
Brand Name
ReliOn™ Confirm/Micro Control
Version/Model Number
710005
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
-
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
-
Product Code
JJX
Product Code Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Public Device Record Key
9681b8ac-8d38-4c4c-9c88-4352fa8e679b
Public Version Date
March 15, 2022
Public Version Number
1
DI Record Publish Date
March 07, 2022
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 |