What is the regulation number for Biohazard Bag?

I am trying to determine the regulation number for simple plastic biohazard bags.

The closest I found was 864.3250 (Specimen transport and storage container).

Any thoughts?

A specimen container has a diagnostic role, therefore is a medical device.

In my opinion, a traditional “red bag”, i.e. a disposal bag for biohazardous items and materials, intended to go directly into a biohazardous waste stream, isn’t a medical device.