Federal (United States) · Regulations
Subpart C
31 sections
31 sections
- 21 C.F.R. § 862.2050General purpose laboratory equipment labeled or promoted for a specific medical use.
- 21 C.F.R. § 862.2100Calculator/data processing module for clinical use.
- 21 C.F.R. § 862.2120Continuous glucose monitor data management system.
- 21 C.F.R. § 862.2140Centrifugal chemistry analyzer for clinical use.
- 21 C.F.R. § 862.2150Continuous flow sequential multiple chemistry analyzer for clinical use.
- 21 C.F.R. § 862.2160Discrete photometric chemistry analyzer for clinical use.
- 21 C.F.R. § 862.2170Micro chemistry analyzer for clinical use.
- 21 C.F.R. § 862.2230Chromatographic separation material for clinical use.
- 21 C.F.R. § 862.2250Gas liquid chromatography system for clinical use.
- 21 C.F.R. § 862.2260High pressure liquid chromatography system for clinical use.
- 21 C.F.R. § 862.2265High throughput genomic sequence analyzer for clinical use.
- 21 C.F.R. § 862.2270Thin-layer chromatography system for clinical use.
- 21 C.F.R. § 862.2300Colorimeter, photometer, or spectrophotometer for clinical use.
- 21 C.F.R. § 862.2310Clinical sample concentrator.
- 21 C.F.R. § 862.2320Beta or gamma counter for clinical use.
- 21 C.F.R. § 862.2400Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
- 21 C.F.R. § 862.2485Electrophoresis apparatus for clinical use.
- 21 C.F.R. § 862.2500Enzyme analyzer for clinical use.
- 21 C.F.R. § 862.2540Flame emission photometer for clinical use.
- 21 C.F.R. § 862.2560Fluorometer for clinical use.
- 21 C.F.R. § 862.2570Instrumentation for clinical multiplex test systems.
- 21 C.F.R. § 862.2680Microtitrator for clinical use.
- 21 C.F.R. § 862.2700Nephelometer for clinical use.
- 21 C.F.R. § 862.2720Plasma oncometer for clinical use.
- 21 C.F.R. § 862.2730Osmometer for clinical use.
- 21 C.F.R. § 862.2750Pipetting and diluting system for clinical use.
- 21 C.F.R. § 862.2800Refractometer for clinical use.
- 21 C.F.R. § 862.2850Atomic absorption spectrophotometer for clinical use.
- 21 C.F.R. § 862.2860Mass spectrometer for clinical use.
- 21 C.F.R. § 862.2900Automated urinalysis system.
- 21 C.F.R. § 862.2920Plasma viscometer for clinical use.