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Part 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES

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Details about Part 866

MEDICAL DEVICES - IMMUNOLOGY AND MICROBIOLOGY DEVICES

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Part 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES

Description

Official eCFR Link

§866.1 - Scope.

§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.

§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

§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 -

§866.2850 - Automated zone reader.

§866.2900 - Microbiological specimen collection and transport device.

§866.3 - Effective dates of requirement for premarket approval.

§866.3010 -

§866.3020 - Adenovirus serological reagents.

§866.3035 -

§866.3040 -

§866.3045 - In vitro diagnostic device for

§866.3050 - Beta-glucan serological assays.

§866.3060 -

§866.3065 -

§866.3085 -

§866.3110 -

§866.3120 - Chlamydia serological reagents.

§866.3125 -

§866.3130 - Clostridium difficile toxin gene amplification assay.

§866.3135 -

§866.3140 -

§866.3145 - Coxsackievirus serological reagents.

§866.3165 -

§866.3175 - Cytomegalovirus serological reagents.

§866.3200 -

§866.3205 - Echovirus serological reagents.

§866.3210 - Endotoxin assay.

§866.3215 - Device to detect and measure non-microbial analyte(s) in human clinical specimens to aid in assessment of patients with suspected sepsis.

§866.3220 -

§866.3225 - Enterovirus nucleic acid assay.

§866.3235 - Epstein-Barr virus serological reagents.

§866.3240 - Equine encephalomyelitis virus serological reagents.

§866.3250 -

§866.3255 -

§866.3270 -

§866.3280 -

§866.3290 - Gonococcal antibody test (GAT).

§866.3300 -

§866.3305 - Herpes simplex virus serological assays.

§866.3309 - Herpes virus nucleic acid-based cutaneous and mucocutaneous lesion panel.

§866.3310 - Hepatitis A virus (HAV) serological assays.

§866.3320 -

§866.3328 - Influenza virus antigen detection test system.

§866.3330 - Influenza virus serological reagents.

§866.3332 - Reagents for detection of specific novel influenza A viruses.

§866.3336 - John Cunningham Virus serological reagents.

§866.3340 -

§866.3350 -

§866.3355 -

§866.3360 - Lymphocytic choriomeningitis virus serological reagents.

§866.3361 - Mass spectrometer system for clinical use for the identification of microorganisms.

§866.3460 - Rabiesvirus immunofluorescent reagents.

§866.4830 - Rocket immunoelectrophoresis equipment.