OYZ
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Group A Streptococcus Nucleic Acid Amplification Assay System
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3740
- Medical specialty
- Microbiology
- FDA definition
- An in vitro diagnostic test for the detection of Streptococcuc pyogenes (Group A beta hemolytic Streptococcus) in throat swab specimens from symptomatic patients.
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| Record | Firm | Date |
|---|---|---|
| STREPTOCOCCUS APP. SEROLOGICAL REAGENTS (K122019) | Meridian Bioscience, Inc. | 2012-09-13 |
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