SCH

Ldt, Approved By Nys Clep

Product code: SCH
Device name: Ldt, Approved By Nys Clep
Device class: Class N
Medical specialty: Unknown
Marketing pathway: Enforcement Discretion

FDA classification definition

Laboratory developed tests (LDTs) that are approved by the New York State Department of Health Clinical Laboratory Evaluation Program (NYS CLEP) described in section V.B.2 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: SCH

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