JST · Kit, Fastidious Organisms
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JST |
|---|---|
| Device Name | Kit, Fastidious Organisms |
| Regulation | 21 CFR 866.2660 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
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.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K962423 | BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM | Becton Dickinson Microbiology Systems | Aug 2, 1996 | SESE |
| K854732 | API 50 CHB (CULTURE MEDIA) | Dms Products, Inc. | Mar 4, 1986 | SESE |
| K841661 | SYNTHETIC BROTH A.O.A.C. | Oxoid U.S.A., Inc. | May 11, 1984 | SESE |
| K832239 | RIM-HAEMOPHILUS 2 | Austin Biological Laboratories | Aug 12, 1983 | SESE |
| K832051 | RIM-HAEMOPHILUS 1 & 2 | Austin Biological Laboratories | Aug 12, 1983 | SESE |
| K831349 | STREPTOCOCUS ID PLATE | Granite Diagnostics, Inc. | May 16, 1983 | SESE |
Top Applicants
- Austin Biological Laboratories — 2 clearances
- Becton Dickinson Microbiology Systems — 1 clearance
- Dms Products, Inc. — 1 clearance
- Granite Diagnostics, Inc. — 1 clearance
- Oxoid U.S.A., Inc. — 1 clearance
