21 CFR 866.2660 — Kit, Anaerobic Identification
Microbiology (MI) · Part 866 Subpart C—Microbiology Devices · § 866.2660
Identification
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| JSP | Kit, Anaerobic Identification | 1 | 18 | |
| JSR | Kit, Identification, Dermatophyte | 1 | 1 | |
| JSS | Kit, Identification, Enterobacteriaceae | 1 | 49 | |
| JST | Kit, Fastidious Organisms | 1 | 6 | |
| JSW | Kit, Identification, Glucose Nonfermenter | 1 | 6 | |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 | 17 | |
| JSY | Kit, Identification, Mycobacteria | 1 | 5 | |
| JSZ | Kit, Identification, Pseudomonas | 1 | 1 | |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 1 | 244 | |
| JWX | Kit, Screening, Staphylococcus Aureus | 1 | 20 | |
| JWZ | Kit, Screening, Trichomonas | 1 | 11 | |
| JXA | Kit, Screening, Urine | 1 | 44 | |
| JXB | Kit, Identification, Yeast | 1 | 16 | |
| JXC | Kit, Screening, Yeast | 1 | 6 | |
| LIB | Device, General Purpose, Microbiology, Diagnostic | 1 | 43 | |
| LJG | Quality Control Slides | 1 | 27 | |
| LLH | Reagents, Clostridium Difficile Toxin | 1 | 42 | |
| LQL | Gram Positive Identification Panel | 1 | 11 | |
| LQM | Gram Negative Identification Panel | 1 | 7 | |
| LRH | Instrument For Auto Reader Of Overnight Microorganism Identification System | 1 | 4 | |
| LSC | Neisseria Controls | 1 | 7 | |
| LTS | Test Reagents, Neisseria Gonorrhoeae Biochemical | 1 | 1 | |
| MCB | Antigen, C. Difficile | 1 | 10 | |
| MJK | Dna Probe, Trichomonas Vaginalis | 1 | 1 | |
| MJM | Dna Probe, Gardnerella Vaginalis | 1 | 2 | |
| MLA | Dna Probe, Yeast | 1 | 2 | |
| MXB | Test, Vaginal, Bacterial Sialidase | 1 | 2 | |
| NZS | Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Rna, Yeast | 1 | 3 | |
| OMN | C. Difficile Nucleic Acid Amplification Test Assay | 1 | 5 |
