Product code
QIP: Rickettsia spp. (spotted fever group or typhus group) serological reagents
FDA product code · Not Classified · Microbiology
Key facts
| Product code | QIP |
|---|---|
| Device | Rickettsia spp. (spotted fever group or typhus group) serological reagents |
| Device class | Not Classified |
| Review panel | Microbiology |
| Submission type | Contact ODE |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | Tests or reagents used to detect IgG and/or IgM antibodies to Ricketsia spp. (Spotted Fever Group or Typhus Group) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Ricketsia spp. in patients suspected of exposure. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None 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