GroundRules
21 CFR 862.3950: Vancomycin 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 862—CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
- Subpart D—Clinical Toxicology Test Systems
(a) Identification. A vancomycin test system is a device intended to measure vancomycin, an antibiotic drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of vancomycin overdose and in monitoring the level of vancomycin to ensure appropriate therapy.
(b) Classification. Class II.
Collected 2026-08-27T02:24:47Z. Source file · JSON