§ 866.5170. Breast milk immunological test system.
78 words·~1 min read·
/us/cfr/t21/s§ 866.5170·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. A breast milk immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the breast milk proteins.
(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. [47 FR 50823, Nov. 9, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, 2001]