Duns Number:835772872
Device Description: PTS Panels® Creatinine Test Strips are in vitro diagnostic devices used to monitor creatin PTS Panels® Creatinine Test Strips are in vitro diagnostic devices used to monitor creatinine levels in human whole blood. These test strips must be used in conjunction with a CardioChek PA analyzer.
Catalog Number
1720
Brand Name
PTS Panels® Creatinine Test Strips
Version/Model Number
1720
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 01, 2019
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
K010456,K010456
Product Code
JFY
Product Code Name
ENZYMATIC METHOD, CREATININE
Public Device Record Key
36580891-d6f5-45f2-b98b-f671773d14dc
Public Version Date
April 13, 2022
Public Version Number
5
DI Record Publish Date
July 15, 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 |