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U.S. Department of Health and Human Services

Product Classification
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Device group a streptococcus nucleic acid amplification assay system
Regulation Description Streptococcus spp. serological reagents.
Definition An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.
Physical State May include automated/manual isothermal nucleic acid amplification, polymerase chain reaction, ligase chain reaction, sequence-based amplification
Technical Method Uses nucleic acid amplification technology to detect Group A Sreptococci
Target Area Throat Swab Specimen
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeOYZ
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3740
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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