FDA 21 CFR Part 866 Immunology and Microbiology Devices

FDA 21 CFR Part 866 Immunology and Microbiology Devices
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Table of contents

Subpart A - General Provisions

866.1 Scope.

866.3 Effective dates of requirement for premarket approval.

866.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

Subpart B - Diagnostic Devices

866.1620 Antimicrobial susceptibility test disc.

866.1640 Antimicrobial susceptibility test powder.

866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

866.1700 Culture medium for antimicrobial susceptibility tests.

Subpart C - Microbiology Devices

866.2050 Staphylococcal typing bacteriophage.

866.2120 Anaerobic chamber.

866.2160 Coagulase plasma.

866.2170 Automated colony counter.

866.2180 Manual colony counter.

866.2190 Automated image assessment system for microbial colonies on solid culture media.

866.2300 Multipurpose culture medium.

866.2320 Differential culture medium.

866.2330 Enriched culture medium.

866.2350 Microbiological assay culture medium.

866.2360 Selective culture medium.

866.2390 Transport culture medium.

866.2410 Culture medium for pathogenic Neisseria spp.

866.2420 Oxidase screening test for gonorrhea.

866.2440 Automated medium dispensing and stacking device.

866.2450 Supplement for culture media.

866.2480 Quality control kit for culture media.

866.2500 Microtiter diluting and dispensing device.

866.2540 Microbiological incubator.

866.2560 Microbial growth monitor.

866.2580 Gas-generating device.

866.2600 Wood's fluorescent lamp.

866.2660 Microorganism differentiation and identification device.

866.2680 Streptococcus spp. nucleic acid-based assay.

866.2850 Automated zone reader.

866.2900 Microbiological specimen collection and transport device.

Subpart D - Serological Reagents

Subpart E - Immunology Laboratory Equipment and Reagents

Subpart F - Immunological Test Systems, (and)

Subpart G - Tumor Associated Antigen immunological Test Systems

FDA 21 CFR Part 866 Immunology and Microbiology Devices:

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