TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES

subpart f - IMMUNOLOGICAL TEST SYSTEMS

866.5800 - Seminal fluid (sperm) immunological test system.

  (a) Identification. A seminal fluid (sperm) immunological test system is a device that consists of the reagents used for legal purposes to identify and differentiate animal and human semen. The test results may be used as court evidence in alleged instances of rape and other sex-related crimes.

  (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 866.9.

[54 FR 25047, June 12, 1989, as amended at 66 FR 38793, July 25, 2001]