Clinical Laboratory Instruments

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Clinical Chemistry and Clinical Toxicology Devices
  7. Clinical Laboratory Instruments

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Section
862.2050

General purpose laboratory equipment labeled or promoted for a specific medical use.

Section
862.2100

Calculator/data processing module for clinical use.

Section
862.2120

Continuous glucose monitor data management system.

Section
862.2140

Centrifugal chemistry analyzer for clinical use.

Section
862.2150

Continuous flow sequential multiple chemistry analyzer for clinical use.

Section
862.2160

Discrete photometric chemistry analyzer for clinical use.

Section
862.2170

Micro chemistry analyzer for clinical use.

Section
862.2230

Chromatographic separation material for clinical use.

Section
862.2250

Gas liquid chromatography system for clinical use.

Section
862.2260

High pressure liquid chromatography system for clinical use.

Section
862.2265

High throughput genomic sequence analyzer for clinical use.

Section
862.2270

Thin-layer chromatography system for clinical use.

Section
862.2300

Colorimeter, photometer, or spectrophotometer for clinical use.

Section
862.2310

Clinical sample concentrator.

Section
862.2320

Beta or gamma counter for clinical use.

Section
862.2400

Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use.

Section
862.2485

Electrophoresis apparatus for clinical use.

Section
862.2500

Enzyme analyzer for clinical use.

Section
862.2540

Flame emission photometer for clinical use.

Section
862.2560

Fluorometer for clinical use.

Section
862.2570

Instrumentation for clinical multiplex test systems.

Section
862.2680

Microtitrator for clinical use.

Section
862.2700

Nephelometer for clinical use.

Section
862.2720

Plasma oncometer for clinical use.

Section
862.2730

Osmometer for clinical use.

Section
862.2750

Pipetting and diluting system for clinical use.

Section
862.2800

Refractometer for clinical use.

Section
862.2850

Atomic absorption spectrophotometer for clinical use.

Section
862.2860

Mass spectrometer for clinical use.

Section
862.2900

Automated urinalysis system.

Section
862.2920

Plasma viscometer for clinical use.