21 C.F.R. · Food and Drugs
21 C.F.R. § 866.5590

Lipoprotein X immunolog-ical test system.

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Regulatory Text

21 C.F.R. § 866.5590 — Lipoprotein X immunolog-ical test system.

§ 866.5590 Lipoprotein X immunolog­ical test system. (a) Identification. A lipoprotein X immunological test system is a device that consists of the reagents used to measure by immunochemical techniques lipoprotein X (a high-density lipoprotein) in serum and other body fluids. Measurement of lipoprotein X aids in the diagnosis of obstructive liver disease. (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 § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]

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21 C.F.R. § 866.5590
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