← FDA Medical Device Classifications
Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System
PGX · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.2680
Classification
- FDA Product Code
PGX- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 866.2680
- Review panel
- MI
- Medical specialty
- Microbiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
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.
Market data
- Cleared 510(k) submissions
- 13
- Registered establishments
- 17
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown