Part 866 Subpart C—Microbiology Devices
FDA submissions for Part 866 Subpart C—Microbiology Devices in the Microbiology (MI) review panel, including product codes and regulations.
Section range: §§ 866.2050–866.2950
CFR Part: 866
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| GTL | Phages, Staphylococcal Typing, All Types | 866.2050 | 1 | 0 |
| OUS | Methicillin Resistant Staphylococcus Aureus/Methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt | 866.2050 | 1 | 2 |
| JTM | Anaerobic Box Glove | 866.2120 | 1 | 1 |
| JTL | Plasma, Coagulase, Human, Horse And Rabbit | 866.2160 | 1 | 12 |
| KZB | Automated Colony Counter | 866.2170 | 1 | 1 |
| KZC | Manual Colony Counter | 866.2180 | 1 | 0 |
| PPU | Microbial Colony Image Assessment System | 866.2190 | 2 | 3 |
| QQY | Culture Plate Imaging System For Qualitative Assessment Of Resistant Organisms | 866.2190 | 2 | 2 |
| JSG | Culture Media, Non-Selective And Non-Differential | 866.2300 | 1 | 209 |
| JSE | Culture Media, Multiple Biochemical Test | 866.2320 | 1 | 53 |
| JSF | Culture Media, Single Biochemical Test | 866.2320 | 1 | 87 |
| JSH | Culture Media, Non-Selective And Differential | 866.2320 | 1 | 146 |
| KZI | Culture Media, Enriched | 866.2330 | 1 | 51 |
| JRZ | Media, Culture, Amino Acid Assay | 866.2350 | 1 | 0 |
| JSA | Culture Media, Antibiotic Assay | 866.2350 | 1 | 8 |
| JSB | Culture Media, Vitamin Assay | 866.2350 | 1 | 0 |
| JSC | Culture Media, General Nutrient Broth | 866.2350 | 1 | 52 |
| JSD | Culture Media, Selective Broth | 866.2360 | 1 | 26 |
| JSI | Culture Media, Selective And Differential | 866.2360 | 1 | 285 |
| JSJ | Culture Media, Selective And Non-Differential | 866.2360 | 1 | 307 |
| PQZ | Gbs Culture Media, Selective And Differential | 866.2360 | 1 | 4 |
| JSL | Culture Media, Anaerobic Transport | 866.2390 | 1 | 8 |
| JSM | Culture Media, Non-Propagating Transport | 866.2390 | 1 | 111 |
| JSN | Culture Media, Propagating Transport | 866.2390 | 1 | 13 |
| QMC | Transport Medium, Notified Per The Vtm Guidance | 866.2390 | 1 | 0 |
| JTY | Culture Media, For Isolation Of Pathogenic Neisseria | 866.2410 | 2 | 83 |
| LGA | Device, Oxidase Test For Gonorrhea | 866.2420 | 3 | 0 |
| JTB | Device, Media Dispensing/Stacking | 866.2440 | 1 | 2 |
| JSK | Supplement, Culture Media | 866.2450 | 1 | 70 |
| JTR | Kit, Quality Control For Culture Media | 866.2480 | 1 | 12 |
| JTC | Device, Microtiter Diluting/Dispensing | 866.2500 | 1 | 66 |
| JTQ | Bath, Incubators/Water, All | 866.2540 | 1 | 12 |
| JTA | Monitor, Microbial Growth | 866.2560 | 1 | 11 |
| LJF | Device, Antimicrobial Drug Removal | 866.2560 | 1 | 4 |
| MDB | System, Blood Culturing | 866.2560 | 1 | 67 |
| MZC | System, Detection, Bacterial, For Platelet Transfusion Products | 866.2560 | 1 | 0 |
| QBQ | System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture | 866.2560 | 1 | 1 |
| KZJ | Device, Gas Generating | 866.2580 | 1 | 18 |
| GMB | Light, Wood'S, Fluorescence | 866.2600 | 1 | 0 |
| JSP | Kit, Anaerobic Identification | 866.2660 | 1 | 18 |
| JSR | Kit, Identification, Dermatophyte | 866.2660 | 1 | 1 |
| JSS | Kit, Identification, Enterobacteriaceae | 866.2660 | 1 | 49 |
| JST | Kit, Fastidious Organisms | 866.2660 | 1 | 6 |
| JSW | Kit, Identification, Glucose Nonfermenter | 866.2660 | 1 | 6 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 866.2660 | 1 | 17 |
| JSY | Kit, Identification, Mycobacteria | 866.2660 | 1 | 5 |
| JSZ | Kit, Identification, Pseudomonas | 866.2660 | 1 | 1 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 866.2660 | 1 | 244 |
| JWX | Kit, Screening, Staphylococcus Aureus | 866.2660 | 1 | 20 |
| JWZ | Kit, Screening, Trichomonas | 866.2660 | 1 | 11 |
| JXA | Kit, Screening, Urine | 866.2660 | 1 | 44 |
| JXB | Kit, Identification, Yeast | 866.2660 | 1 | 16 |
| JXC | Kit, Screening, Yeast | 866.2660 | 1 | 6 |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 866.2660 | 1 | 43 |
| LJG | Quality Control Slides | 866.2660 | 1 | 27 |
| LLH | Reagents, Clostridium Difficile Toxin | 866.2660 | 1 | 42 |
| LQL | Gram Positive Identification Panel | 866.2660 | 1 | 11 |
| LQM | Gram Negative Identification Panel | 866.2660 | 1 | 7 |
| LRH | Instrument For Auto Reader Of Overnight Microorganism Identification System | 866.2660 | 1 | 4 |
| LSC | Neisseria Controls | 866.2660 | 1 | 7 |
| LTS | Test Reagents, Neisseria Gonorrhoeae Biochemical | 866.2660 | 1 | 1 |
| MCB | Antigen, C. Difficile | 866.2660 | 1 | 10 |
| MJK | Dna Probe, Trichomonas Vaginalis | 866.2660 | 1 | 1 |
| MJM | Dna Probe, Gardnerella Vaginalis | 866.2660 | 1 | 2 |
| MLA | Dna Probe, Yeast | 866.2660 | 1 | 2 |
| MXB | Test, Vaginal, Bacterial Sialidase | 866.2660 | 1 | 2 |
| NZS | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast | 866.2660 | 1 | 3 |
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | 866.2660 | 1 | 5 |
| PGX | Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System | 866.2680 | 2 | 13 |
| KZK | Reader, Zone, Automated | 866.2850 | 1 | 3 |
| JTW | System, Transport, Aerobic | 866.2900 | 1 | 43 |
| JTX | Transport Systems, Anaerobic | 866.2900 | 1 | 8 |
| LIO | Device, Specimen Collection | 866.2900 | 1 | 63 |
| LKS | Device, Parasite Concentration | 866.2900 | 1 | 13 |
| OID | Sex Crimes / Sexual Assault / Suspect Evidence Collection Kit (Excludes Hiv Testing) | 866.2900 | 1 | 0 |
| SEP | Device For Home Collection And Transport Of Vaginal Specimens By Lay Users For Use In An Approved Hpv Molecular Assay | 866.2920 | 2 | 2 |
| QBD | Microbial Nucleic Acid Storage And Stabilization Device | 866.2950 | 2 | 17 |
