[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2001] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR866.2500] [Page 239] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES--(Continued) PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES--Table of Contents Subpart C--Microbiology Devices Sec. 866.2500 Microtiter diluting and dispensing device. (a) Identification. A microtiter diluting and dispensing device is a mechanical device intended for medical purposes to dispense or serially dilute very small quantities of biological or chemical reagents for use in various diagnostic procedures. (b) Classification. Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989]