Duns Number:835772872
Device Description: PTS PANELS® Multi-Chemistry Controls contain cholesterol, triglycerides, glucose, and keto PTS PANELS® Multi-Chemistry Controls contain cholesterol, triglycerides, glucose, and ketones. The analyte(s) in this solution react with test strips to produce a color. The darker the color is, the higher the analyte concentration. The result for each level of control should be in the range specified on the Quality Control Range Card included with the controls. Controls should be run to verify the test system performance, when results are questionable, or to comply with your facility’s quality control requirements.
Catalog Number
721
Brand Name
pts panels® Multi-Chemistry Controls
Version/Model Number
721
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
-
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
-
Product Code
JJY
Product Code Name
Multi-analyte controls, all kinds (assayed)
Public Device Record Key
877d571e-d722-4be9-b993-0cde588e9711
Public Version Date
April 13, 2022
Public Version Number
3
DI Record Publish Date
September 18, 2018
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 |