OraQuick Ebola Rapid Antigen Test— 510(k) DEN190025

Unknown

OraSure Technologies, Inc.

FDA 510(k) clearance DEN190025 for OraQuick Ebola Rapid Antigen Test, Unknown on 2019-10-10. Applicant: OraSure Technologies, Inc..

Clearance details

Applicant: OraSure Technologies, Inc.
Product code: Code QID
Advisory panel: Microbiology
Date received: 2019-05-13
Decision date: 2019-10-10
Decision: Unknown
Clearance type: Direct
Location: Bethlehem, PA, US

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