Duns Number:835772872
Device Description: PTS Panels CHOL+HDL test strips are in vitro diagnostic devices used to monitor HDL choles PTS Panels CHOL+HDL test strips are in vitro diagnostic devices used to monitor HDL cholesterol and total cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA analyzer.
Catalog Number
1821
Brand Name
PTS Panels® CHOL+HDL Test Strips
Version/Model Number
1821
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
K162282,K162282
Product Code
CHH
Product Code Name
ENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL
Public Device Record Key
78089730-8689-41be-bbe7-93643cb5d86d
Public Version Date
April 14, 2022
Public Version Number
4
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 |