OYZ — Group A Streptococcus Nucleic Acid Amplification Assay System Class I
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 |