Product code
PGX: Groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system
FDA product code · Class II · Microbiology
Key facts
| Product code | PGX |
|---|---|
| Device | Groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system |
| Device class | Class II |
| Regulation number | 866.2680 |
| Review panel | Microbiology |
| Medical specialty | Microbiology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- 10–99 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 10–99 UDI devices (GUDID)
- 1–9 MAUDE adverse event reports
- 1–9 Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database