Duns Number:600039072
Device Description: The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quan The Dario Blood Glucose Test Strips are for use with the Dario Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.
Catalog Number
-
Brand Name
50 Dario Blood Glucose Test Strip
Version/Model Number
1024-05
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
K150817
Product Code
CGA
Product Code Name
Glucose Oxidase, Glucose
Public Device Record Key
4d36cf50-4b3d-450a-93eb-1dc10e15e7bf
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 25, 2018
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. | 19 |