JSY · Kit, Identification, Mycobacteria
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JSY |
|---|---|
| Device Name | Kit, Identification, Mycobacteria |
| 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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K943051 | MYCOAKT M. TUBERCULOSIS CUULTURE ID KIT | Dynagen, Inc. | Mar 13, 1995 | SESE |
| K943050 | MYCOAKT M KANSASII CULTURE ID KIT | Dynagen, Inc. | Mar 13, 1995 | SESE |
| K943049 | MYCOAKT M. AVIUM CULTURE ID KIT | Dynagen, Inc. | Mar 13, 1995 | SESE |
| K880990 | ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION | Alpha-Tec Systems, Inc. | Mar 24, 1988 | SESE |
| K830211 | API TB-IDENT* | Analytical Products, Inc. | Mar 24, 1983 | SESE |
Top Applicants
- Dynagen, Inc. — 3 clearances
- Alpha-Tec Systems, Inc. — 1 clearance
- Analytical Products, Inc. — 1 clearance
