GroundRules
21 CFR 866.5580: Alpha-1-lipoprotein immunological test system.
Where this section sits in the code
- 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
(a) Identification. An alpha-1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement of alpha-1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).
(b) Classification. Class II (performance standards).
Collected 2026-08-27T02:24:47Z. Source file · JSON