QIQ — Orientia Spp. (Scrub Typhus) Serological Reagents Class N
FDA product code QIQ covers "Orientia Spp. (Scrub Typhus) Serological Reagents", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- QIQ
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
Definition
Tests or reagents used to detect IgG and/or IgM antibodies to Orientia spp. (Scrub Typhus) in human serum or plasma. Used to aid in the diagnosis of either present or past infection with Orientia spp. in patients suspected of exposure.