Product code OYZ— Microbiology

STREPTOCOCCUS APP. SEROLOGICAL REAGENTS

Classification name: Group A Streptococcus Nucleic Acid Amplification Assay System
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Total cleared: 1
First cleared: 2012-09-13
Most recent: 2012-09-13

FDA classification definition

“An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.”
— U.S. Food and Drug Administration, device classification record for product code OYZ under 21 CFR 866.3740, via openFDA

Market context for product code OYZ

FDA has cleared 1 device under product code OYZ, all in 2012, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code OYZ

Meridian Bioscience, Inc.1 clearance

Recent clearances under product code OYZ

K122019 — STREPTOCOCCUS APP. SEROLOGICAL REAGENTSMeridian Bioscience, Inc.·2012-09-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.