FDA-Device2014-04-02Class II
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
AMS Diagnostics, LLC
Hazard
Marketing the devices outside 510(k) requirements
Sold states
Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
Affected count
13 kits
Manufactured in
1790 N Commerce Pkwy, N/A, Weston, FL, United States
Products
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1268-2014Don't want to check this manually?
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