Polymer Technology Systems Recalls PTS Detect Cotinine In Vitro Diagnostic
Polymer Technology Systems is recalling PTS Detect Cotinine in vitro diagnostic devices due to a lack of FDA 510(k) clearance.
- Product
- PTS Detect Cotinine, Ref. No. 3061, UPC 381933061017 in vitro diagnostic - Product Usage: The PTS Detect cotinine system provides quantitative measurement of the nicotine metabolite cotinine (25 200 ng/mL) in capillary (fingerstick) or venous whole blood. The test is for…
- Category
- Medical Device
- Distribution
- Distributed nationwide