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Group A Streptococcus Nucleic Acid Amplification Assay System

FDA product code OYZ · 1 cleared devices

Class 1 Microbiology
Regulation
21 CFR 866.3740
Review panel
MI
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2012-09-13 – 2012-09-13

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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