FDA-Device2020-03-11Class II
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 professional use to determine if an individual has been exposed to nicotine.
Polymer Technology Systems, Inc.
Hazard
The firm is removing the product from the market after discussions with the FDA due to lack of 510(k) clearance.
Sold states
Domestic distribution nationwide. Foreign distribution to Belgium, South Africa, South Korea, and Poland.
Affected count
6790
Manufactured in
7736 Zionsville Rd, N/A, Indianapolis, IN, United States
Products
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 professional use to determine if an individual has been exposed to nicotine.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1438-2020Don't want to check this manually?
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