510(k) DEN140005
DEN140005 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "LYRA DIRECT STREP ASSAY". The FDA issued a decision of De Novo Granted on April 16, 2014. The device falls under product code PGX (Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System), a Class II device regulated under 21 CFR 866.2680. Quidel Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 16, 2014
- Date Received
- March 25, 2014
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- Device Class
- Class II
- Regulation Number
- 866.2680
- Review Panel
- MI
- Submission Type
An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.