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OTU — Research Use Only/Pathology Class N

FDA Device Classification

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

Classification Details

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

Definition

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