FDA-Device2022-11-30Class II
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Kamiya Biomedical Company, LLC
Hazard
IgA Reagent may start showing cloudiness over time, which can affect assay performance.
Sold states
Worldwide - US Nationwide distribution in the states of FL, NC, TX, TN, PA, CA, NY, IL, MA and the country of Czech Republic.
Affected count
165
Manufactured in
12779 Gateway Dr S, N/A, Tukwila, WA, United States
Products
K-ASSAY IgA Immunoturbidimetric Assay, REF: KAI-013
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0271-2023Don't want to check this manually?
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