Duns Number:835772872
Device Description: PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to monitor HD PTS Panels® HDL Cholesterol test strips are in vitro diagnostic devices used to monitor HDL cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.
Catalog Number
1714
Brand Name
PTS Panels® HDL Cholesterol Test Strips
Version/Model Number
1714
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K060617,K060617
Product Code
LBR
Product Code Name
LDL & VLDL PRECIPITATION, HDL
Public Device Record Key
dca27f79-a462-4537-9b5b-52750dd0dbcf
Public Version Date
April 14, 2022
Public Version Number
4
DI Record Publish Date
July 22, 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 |