I should write
Diagnostic purpose is information only to determine that you have a medical device based on the Food Drug and Cosmetic Act.
It has nothing to do the with classification, sorry. This information neither determine the class nor any product code, classification CFR, etc.
I kindly suggest the following public information sources to take into consideration, when sharing such information on a public domain like this forum.
CDRH Learn
On the page, please consider the
Overview of Regulatory Requirements: Medical Devices training and the others relating to this subject.
I think all of us have a responsibility to declare, define, share and communicate only the information we absolutely sure in order to prevent rumors, fictions and almost "religious" beliefs rolling over planet earth.
Cheers!