LYRA DIRECT STREP ASSAY

Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System

QUIDEL CORPORATION

The following data is part of a De Novo classification by Quidel Corporation with the FDA for Lyra Direct Strep Assay.

Pre-market Notification Details

• DeNovo ID: DEN140005
• Device Name: LYRA DIRECT STREP ASSAY
• Classification: Groups A, C And G Beta-hemolytic Streptococcus Nucleic Acid Amplification System
• Applicant: QUIDEL CORPORATION 2005 East State St., Suite 100 Athens, OH 45701
• Contact: Ronald H Lollar
• Product Code: PGX
• CFR Regulation Number: 866.2680 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: K133883
• Review Advisory Board: Microbiology
• Classification Advisory: Microbiology
• Type: Post-NSE
• Date Received: 2014-03-25
• Decision Date: 2014-04-16
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30014613311126	DEN140005	000