Product code PGX
- Device name
- Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.2680
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- An in vitro diagnostic test for the detection of Group A, C and G beta hemolytic Streptococcus in throat swab specimens from symptomatic patients.
- Source
- FDA openFDA device classification dataset