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510(k) K122019

STREPTOCOCCUS APP. SEROLOGICAL REAGENTS by Meridian Bioscience, Inc. — Product Code OYZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2012
Date Received
July 10, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Group A Streptococcus Nucleic Acid Amplification Assay System
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.

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