Duns Number:045361136
Device Description: Our B-Ketone Control Solution is intended for use to ensure your meter and test strips are Our B-Ketone Control Solution is intended for use to ensure your meter and test strips are working together properly. Use with EKF Diagnostics' B-Ketone Test Strips only.
Catalog Number
7024-204
Brand Name
B-Ketone Control Solution
Version/Model Number
7024-204
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)
Yes
Over the Counter (OTC)
-
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
797ee340-6932-4b43-95c7-423fbd178bf1
Public Version Date
November 26, 2019
Public Version Number
1
DI Record Publish Date
November 18, 2019
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 | 69 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 86 |