Product code OYZ

Device name: Group A Streptococcus Nucleic Acid Amplification Assay System
Medical specialty: Microbiology
Device class: 1
Regulation number: 866.3740
Review panel: MI
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: N
Summary malfunction reporting: Eligible
Definition: An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.
Source: FDA openFDA device classification dataset

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K122019	STREPTOCOCCUS APP. SEROLOGICAL REAGENTS	Meridian Bioscience, Inc.	2012-09-13

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00840733102127	Alethia™ Group A Streptococcus External Control Kit	MERIDIAN BIOSCIENCE, INC.	2019-01-09
00840733102264	Alethia™ Group A Streptococcus	MERIDIAN BIOSCIENCE, INC.	2019-01-09
00840733101328	illumigene Group A Streptococcus External Control Kit	MERIDIAN BIOSCIENCE, INC.	2016-09-23
00840733101335	illumigene Group A Streptococcus	MERIDIAN BIOSCIENCE, INC.	2016-09-23

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