OTV — Research Use Only/Clinical Chemistry Devices Class N

FDA Device Classification

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

Classification Details

Product Code
OTV
Device Class
Class N
Regulation Number
Submission Type
Review Panel
CH
Medical Specialty
Unknown
Implant
No

Definition

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