fda
2 records
FDA Device Recall: FaStep COVID-19 IgG/IgM Rapid Test Device Qualitative detection and differentia
2021-09-08
Class II — Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
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FDA Device Recall: Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diag
2021-09-08
Class II — Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emergency Use Authorization.
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