SCF — Ldt, Unmet Need Within An Integrated Healthcare System Class N
FDA product code SCF covers "Ldt, Unmet Need Within An Integrated Healthcare System", a Class N medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- SCF
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Unknown
- Implant
- No
Definition
Laboratory developed tests (LDTs) manufactured and performed by a laboratory integrated within a healthcare system to meet an unmet need of patients receiving care within the same healthcare system as described in section V.B.3 of the preamble to the LDT Final Rule (89 FR 37286).