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OQS

Laboratory Developed Test

Product code
OQS
Device name
Laboratory Developed Test
Device class
Class N
Medical specialty
Unknown
Marketing pathway
Enforcement Discretion

FDA classification definition

Laboratory Developed Test

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

Official FDA classification page: OQS
Classification and pathway per current FDA publications. Data from openFDA (CC0).