OraQuick Ebola Rapid Antigen Test— 510(k) DEN190025
UnknownOraSure Technologies, Inc.
FDA 510(k) clearance DEN190025 for OraQuick Ebola Rapid Antigen Test, Unknown on 2019-10-10. Applicant: OraSure Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- OraSure Technologies, Inc.
- Product code
- Code QID
- Device class
- Class 2
- Regulation
- 21 CFR 866.4002
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Bethlehem, PA, US
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