SDN — Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps Class U
FDA product code SDN covers "Serology Test Used For Screening Of Cadaveric (Non-Heart-Beating) Donors Of Blood Or Blood Products Or Hct/Ps", a Class U medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SDN
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Unknown
- Implant
- No
Definition
For the qualitative detection of antibodies or antigens to infectious disease agents in human cadaveric (non-heart-beating) specimens