OYZ — Group A Streptococcus Nucleic Acid Amplification Assay System Class I
FDA product code OYZ covers "Group A Streptococcus Nucleic Acid Amplification Assay System", a Class I medical device regulated under 21 CFR 866.3740. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OYZ
- Device Class
- Class I
- Regulation Number
- 866.3740
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K122019 | meridian bioscience | STREPTOCOCCUS APP. SEROLOGICAL REAGENTS | September 13, 2012 |