FDA-Device2015-11-04Class II
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Sentinel CH SpA
Hazard
Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.
Sold states
Nationwide Distribution.
Affected count
765 kits
Manufactured in
Via Robert Koch 2, N/A, Milano, N/A, Italy
Products
Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0164-2016Don't want to check this manually?
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