Group A Streptococcus Nucleic Acid Amplification Assay System
The Group A Streptococcus Nucleic Acid Amplification Assay System is an in vitro diagnostic test for the qualitative detection of Streptococcus pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients. It is classified as Class 1 (FDA Class 1), subject to general controls with a 510(k) submission required. The product code is OYZ, with regulation number 866.3740 under the Microbiology medical specialty.
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Basic Information
- Product Code
- OYZ
- Device Class
- FDA class 1
- Regulation Number
- 866.3740
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K122019 | STREPTOCOCCUS APP. SEROLOGICAL REAGENTS | Sep 13, 2012 | Substantially Equivalent | Meridian Bioscience, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.