Duns Number:835772872
Device Description: Cotinine, the major metabolite of nicotine, indicates exposure to tobacco and other nicoti Cotinine, the major metabolite of nicotine, indicates exposure to tobacco and other nicotine-containing products. Cotinine has a longer half-life than nicotine, which allows for a more accurate assessment of smoking or exposure status and better monitoring of progress in smoking cessation programs.1 Because of its longer half-life and relative ease of detection, cotinine is the choice metabolite to assess exposure to nicotine. The amount of cotinine present in the blood is proportional to the amount and recency of nicotine exposure. The PTS Detect cotinine system provides measurement of cotinine in capillary (fingerstick) or venous whole blood.
Catalog Number
3061
Brand Name
PTS Detect® Cotinine System
Version/Model Number
3061
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2020
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MRS
Product Code Name
Test system, nicotine, cotinine, metabolites
Public Device Record Key
46bf859e-f067-4c4c-9f6d-e5438c4e8d44
Public Version Date
April 13, 2022
Public Version Number
3
DI Record Publish Date
October 08, 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 |