Definition: An In Vitro Diagnostic Test For The Detection Of Streptococcuc Pyogenes (Group A Beta Hemolytic Streptococcus) In Throat Swab Specimens From Symptomatic Patients.
| Device Type ID | 3545 |
| Device Name | Group A Streptococcus Nucleic Acid Amplification Assay System |
| 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 Description | Streptococcus Spp. Serological Reagents. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.3740 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | OYZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |