JXB · Kit, Identification, Yeast
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JXB |
|---|---|
| Device Name | Kit, Identification, Yeast |
| 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 (16 of 16)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K080719 | YEAST TRAFFIC LIGHT PNA FISH | Advandx, Inc. | Sep 12, 2008 | SESE |
| K062461 | C. ALBICANS PNA FISH | Advandx, Inc. | Oct 25, 2006 | SESE |
| K993554 | YEASTEST | Diagnostic Markers, Inc. | Feb 10, 2000 | SESE |
| K943621 | RAPID YEAST PLUS SYSTEM | Innovative Diagnostic Systems, Inc. | Jan 27, 1995 | SESE |
| K935124 | BACTICARD CANDIDA | Remel Co. | Feb 25, 1994 | SESE |
| K900112 | MICRORING YT | Medical Wire & Equipment Co. | Jul 31, 1990 | SESE |
| K881925 | VITEK YEAST BIOCHEMICAL CARD | Vitek Systems, Inc. | Jun 16, 1988 | SESE |
| K860575 | YEAST IDENTIFICATION PANEL | American Micro Scan | May 13, 1986 | SESE |
| K830286 | YEAST IDENT | Analytical Products, Inc. | Apr 5, 1983 | SESE |
| K802309 | MS-2 IDENTIFICATION SYSTEM | Abbott Laboratories | Dec 1, 1980 | SESE |
| K800803 | NITRATE SWAB-RAPID TEST | Remel Co. | Jul 8, 1980 | SESE |
| K800908 | CAPIK-CANDIDA ALBICANS IDENT. KIT. | Immuno-Mycologics, Inc. | Jun 2, 1980 | SESE |
| K792231 | AMS YEAST BIOCHEMICAL CARD | Vitek Systems, Inc. | Dec 19, 1979 | SESE |
| K790991 | YEAST-PALETTE TM | Micro-Palettes, Inc. | Jun 22, 1979 | SESE |
| K790671 | DERMATOPHYTIN O | Diagnostica, Inc. | May 31, 1979 | SESE |
| K771008 | API 20C | Analytical Products, Inc. | Aug 3, 1977 | SESE |
Top Applicants
- Advandx, Inc. — 2 clearances
- Analytical Products, Inc. — 2 clearances
- Remel Co. — 2 clearances
- Vitek Systems, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
