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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 862 - Clinical Chemistry and Clinical Toxicology Devices |
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Subpart C - Clinical Laboratory Instruments |
| § 862.2050 - General purpose laboratory equipment labeled or promoted for a specific medical use. |
| § 862.2100 - Calculator/data processing module for clinical use. |
| § 862.2120 - Continuous glucose monitor data management system. |
| § 862.2140 - Centrifugal chemistry analyzer for clinical use. |
| § 862.2150 - Continuous flow sequential multiple chemistry analyzer for clinical use. |
| § 862.2160 - Discrete photometric chemistry analyzer for clinical use. |
| § 862.2170 - Micro chemistry analyzer for clinical use. |
| § 862.2230 - Chromatographic separation material for clinical use. |
| § 862.2250 - Gas liquid chromatography system for clinical use. |
| § 862.2260 - High pressure liquid chromatography system for clinical use. |
| § 862.2265 - High throughput genomic sequence analyzer for clinical use. |
| § 862.2270 - Thin-layer chromatography system for clinical use. |
| § 862.2300 - Colorimeter, photometer, or spectrophotometer for clinical use. |
| § 862.2310 - Clinical sample concentrator. |
| § 862.2320 - Beta or gamma counter for clinical use. |
| § 862.2400 - Densitometer/scanner (integrating, reflectance, TLC, or radiochromatogram) for clinical use. |
| § 862.2485 - Electrophoresis apparatus for clinical use. |
| § 862.2500 - Enzyme analyzer for clinical use. |
| § 862.2540 - Flame emission photometer for clinical use. |
| § 862.2560 - Fluorometer for clinical use. |
| § 862.2570 - Instrumentation for clinical multiplex test systems. |
| § 862.2680 - Microtitrator for clinical use. |
| § 862.2700 - Nephelometer for clinical use. |
| § 862.2720 - Plasma oncometer for clinical use. |
| § 862.2730 - Osmometer for clinical use. |
| § 862.2750 - Pipetting and diluting system for clinical use. |
| § 862.2800 - Refractometer for clinical use. |
| § 862.2850 - Atomic absorption spectrophotometer for clinical use. |
| § 862.2860 - Mass spectrometer for clinical use. |
| § 862.2900 - Automated urinalysis system. |
| § 862.2920 - Plasma viscometer for clinical use. |