FDA-Device2018-08-22Class III
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
Tosoh Bioscience Inc
Hazard
Distribution of unapproved product labeling
Sold states
US Distribution to states of: FL, MA, MT, OK, OR and WI.
Affected count
9 CDS
Manufactured in
3600 Gantz Rd, Grove City, OH, United States
Products
Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027 CD contains analyte application manuals for 47 analyte reagent packs for use with the Tosoh AIA (Automated Immuno-Assay) family of analyzers. Each analyte application manual includes a reference section on assay controls in the analyte application manual.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2827-2018Don't want to check this manually?
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