FDA-Device2017-04-05Class II
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Focus Diagnostics Inc
Hazard
After a submission for CLIA database update from Focus Diagnostics to DiaSorin Molecular,the company found that their Legionella IFA device (IF0950) is not 510(k) exempt.
Sold states
Product was distributed to three testing laboratories in California, New Jersey and Virginia
Affected count
196 units
Manufactured in
11331 Valley View St, Cypress, CA, United States
Products
Legionella IFA (IF0950) intended for qualitatively detecting and semi-quantitating human serum antibodies to Legionella pneumophila.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1685-2017Don't want to check this manually?
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