FDA-Device2017-02-01Class II
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
Sekisui Diagnostics P.E.I. Inc.
Hazard
Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.
Sold states
Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka
Affected count
774 Liters bulk and 565 kits
Manufactured in
70 Watts Ave, N/A, Charlottetown, N/A, Canada
Products
Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1078-2017Don't want to check this manually?
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