Following - I am so glad you asked this question as I have asked the same thing to both Ortho and AABB with no direct response.
My question was, is there a requirement for an incubator and centrifuge to be an FDA cleared medical device? We use them throughout the lab and blood bank for specimen centrifugation and for serologic tube testing, and those are not FDA cleared devices. As long as your equipment is maintained and is meeting the requirements of the circular/instructions for use, aren't you compliant?