21 C.F.R. · Food and Drugs
21 C.F.R. § 866.5800

Seminal fluid (sperm) immunological test system.

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Regulatory Text

21 C.F.R. § 866.5800 — Seminal fluid (sperm) immunological test system.

§ 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]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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21 C.F.R. § 866.5800
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The regulatory text of 21 C.F.R. § 866.5800 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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