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-1268-2014

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