OTR

Research Use Only/Immunology Devices

Product code
OTR
Device name
Research Use Only/Immunology Devices
Device class
Class N
Medical specialty
Unknown
Marketing pathway
Enforcement Discretion
Flag
GMP exempt

FDA classification definition

For research use only and for products imported into the US only.

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

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