21 CFR Subpart C - Subpart C—Clinical Laboratory Instruments

  1. § 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
  2. § 862.2100 Calculator/data processing module for clinical use.
  3. § 862.2120 Continuous glucose monitor data management system.
  4. § 862.2140 Centrifugal chemistry analyzer for clinical use.
  5. § 862.2150 Continuous flow sequential multiple chemistry analyzer for clinical use.
  6. § 862.2160 Discrete photometric chemistry analyzer for clinical use.
  7. § 862.2170 Micro chemistry analyzer for clinical use.
  8. § 862.2230 Chromatographic separation material for clinical use.
  9. § 862.2250 Gas liquid chromatography system for clinical use.
  10. § 862.2260 High pressure liquid chromatography system for clinical use.
  11. § 862.2265 High throughput genomic sequence analyzer for clinical use.
  12. § 862.2270 Thin-layer chromatography system for clinical use.
  13. § 862.2300 Colorimeter, photometer, or spectrophotometer for clinical use.
  14. § 862.2310 Clinical sample concentrator.
  15. § 862.2320 Beta or gamma counter for clinical use.
  16. § 862.2400 Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.
  17. § 862.2485 Electrophoresis apparatus for clinical use.
  18. § 862.2500 Enzyme analyzer for clinical use.
  19. § 862.2540 Flame emission photometer for clinical use.
  20. § 862.2560 Fluorometer for clinical use.
  21. § 862.2570 Instrumentation for clinical multiplex test systems.
  22. § 862.2680 Microtitrator for clinical use.
  23. § 862.2700 Nephelometer for clinical use.
  24. § 862.2720 Plasma oncometer for clinical use.
  25. § 862.2730 Osmometer for clinical use.
  26. § 862.2750 Pipetting and diluting system for clinical use.
  27. § 862.2800 Refractometer for clinical use.
  28. § 862.2850 Atomic absorption spectrophotometer for clinical use.
  29. § 862.2860 Mass spectrometer for clinical use.
  30. § 862.2900 Automated urinalysis system.
  31. § 862.2920 Plasma viscometer for clinical use.