FDA-Device2014-04-02Class II
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun 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
167 kits
Manufactured in
1790 N Commerce Pkwy, N/A, Weston, FL, United States
Products
AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1267-2014Don't want to check this manually?
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