Duns Number:835772872
Device Description: PTS Panels® Ketone Test Strips are in vitro diagnostic devices used to monitor ketone leve
Catalog Number
1718
Brand Name
PTS Panels® Ketones Test Strips
Version/Model Number
1718
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 20, 2017
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
K981865,K983860,K981865,K983860
Product Code
JMK
Product Code Name
ACID, ALPHA-KETOBUTYRIC AND NADH (U.V.), HYDROXYBUTYRIC DEHYDROGENASE
Public Device Record Key
df50c36b-adf2-4b1c-82b9-f240fe1fc1d8
Public Version Date
April 14, 2022
Public Version Number
4
DI Record Publish Date
September 08, 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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |