SCJ

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Product code

SCJ

Device name

Ldt, Not Under A Targeted Enforcement Discretion Policy Described In Preamble To Ldt Final Rule

Device class

Class N

Medical specialty

Unknown

Marketing pathway

Enforcement Discretion

FDA classification definition

Laboratory developed tests (LDTs) within the scope of the phaseout policy and not subject to a targeted enforcement discretion policy described in section V.B 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).