SCF

Ldt, Unmet Need Within An Integrated Healthcare System

Product code: SCF
Device name: Ldt, Unmet Need Within An Integrated Healthcare System
Device class: Class N
Medical specialty: Unknown
Marketing pathway: Enforcement Discretion

FDA classification 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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: SCF

Classification and pathway per current FDA publications. Data from openFDA (CC0).