SCE

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

Product code

SCE

Device name

Ivd Offered As Ldt, First Marketed Before May 6, 2024, Not Modified Beyond Scope Described In Preamble To Ldt Final Rule

Device class

Class N

Medical specialty

Unknown

Marketing pathway

Enforcement Discretion

FDA classification definition

Currently marketed in vitro diagnostic products (IVDs) offered as laboratory developed tests (LDTs) that were first marketed prior to May 6, 2024, and not modified following that date or not modified beyond the scope 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).