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510(k) DEN140005

LYRA DIRECT STREP ASSAY by Quidel Corporation — Product Code PGX

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.

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