Duns Number:835772872
Device Description: PTS Panels® Metabolic Chemistry test strips are in vitro diagnostic devices used to monito PTS Panels® Metabolic Chemistry test strips are in vitro diagnostic devices used to monitor glucose; HDL cholesterol; and triglycerides levels in human whole blood. These test strips must be used in conjunction with a CardioChek Plus or CardioChek PA analyzer.
Catalog Number
2400
Brand Name
PTS Panels® Metabolic ChemistryTest Strips
Version/Model Number
2400
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 20, 2022
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
K070017,K070017
Product Code
CGA
Product Code Name
GLUCOSE OXIDASE, GLUCOSE
Public Device Record Key
86a7dadd-c2cc-4609-89c7-3c6bccfe5165
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 |