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OraSure Technologies, Inc.

6 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intend recall (Z-0722-2017)OraSure Technologies, Inc.2016-12-08
OraQuick Ebola Rapid Antigen Test, Product Code 3001-2807; Intended for the qualitative de recall (Z-2403-2016)OraSure Technologies, Inc.2016-08-17
Micro Plate EIA Oral Fluid Positive Control which is a component of the Intercept Micro Pl recall (Z-0477-2009)OraSure Technologies, Inc.2008-12-23
Micro Plate EIA Oral Fluid Negative Control which is a component of the Intercept Micro Pl recall (Z-0478-2009)OraSure Technologies, Inc.2008-12-23
Micro Plate EIA Oral Fluid Cutoff Calibrator which is a component of the Intercept Micro P recall (Z-0479-2009)OraSure Technologies, Inc.2008-12-23
Cannabinoids Intercept Micro Plate EIA 100 plate kit recall (Z-0481-2009)OraSure Technologies, Inc.2008-12-18

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Every clearance here is in the API, with alerts when new ones post.