§864.4020. Analyte specific reagents. — Inbound Citations
21 C.F.R. § 864.4020
Statutory Authority
Cited by 1 regulation in release Current.
Citations to 21 C.F.R. § 864.4020 as a whole
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(a) Analyte specific reagents (ASR's) (§ 864.4020 of this chapter) are restricted devices under section 520(e) of the Federal Food, Drugs, and Cosmetic Act (the act) subject to the restrictions set forth in this section.