510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OYZClass I

Group A Streptococcus Nucleic Acid Amplification Assay System

21 CFR 866.3740 / Microbiology
FDA source (opens on fda.gov)

OYZ is the FDA product code for Group A Streptococcus Nucleic Acid Amplification Assay System, a class I device type, regulated under 21 CFR 866.3740. FDA's definition for this code reads: "An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OYZ
Device name
Group A Streptococcus Nucleic Acid Amplification Assay System
FDA definition
An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.
Regulation
21 CFR 866.3740
Device class
Class I
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OYZ

By decision year
1 clearance under product code OYZ with a decision year between 2012 and 2012, 2012 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OYZ by decision year
YearClearances
20121

Applicants with the most clearances

Product code OYZ
Applicants holding the most 510(k) clearances under product code OYZ
ApplicantClearances
Meridian Bioscience Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code