OYZ · Class I · 21 CFR 866.3740

FDA Product Code OYZ: Group A Streptococcus Nucleic Acid Amplification Assay System

An In Vitro Diagnostic Test For The Detection Of Streptococcuc Pyogenes (group A Beta Hemolytic Streptococcus) In Throat Swab Specimens From Symptomatic Patients.

1
Total
1
Cleared
65d
Avg days
2012
Since

FDA 510(k) Cleared Group A Streptococcus Nucleic Acid Amplification Assay System Devices (Product Code OYZ)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OYZ - Regulatory Context