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OTR — Research Use Only/Immunology Devices Class N

FDA Device Classification

FDA product code OTR covers "Research Use Only/Immunology Devices", a Class N medical device. Submissions are reviewed by the Unknown panel.

Classification Details

Product Code: OTR
Device Class: Class N
Regulation Number
Submission Type
Review Panel: IM
Medical Specialty: Unknown
Implant: No

Definition

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