JSX · Kit, Identification, Neisseria Gonorrhoeae
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JSX |
|---|---|
| Device Name | Kit, Identification, Neisseria Gonorrhoeae |
| 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 (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K960759 | GONOPOX TEST KIT | Medtex Laboratories, Inc. | Sep 18, 1996 | SESE |
| K923566 | NIZYME TEST KIT | Remel Co. | Nov 2, 1992 | SESE |
| K913456 | VISI-NEISSERIA | Kev Connecticut Diagnostics, Inc. | Oct 11, 1991 | SESE |
| K880511 | XACT NEISSERIA | Austin Biological Laboratories | Aug 25, 1988 | SESE |
| K881501 | MODIFIED IDS RAPID NH SYSTEM | Innovative Diagnostic Systems, Inc. | May 18, 1988 | SESE |
| K870117 | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST | Pro-Lab, Inc. | Mar 20, 1987 | SESE |
| K853544 | QUAD FERM + | Analytical Products, Inc. | Sep 5, 1985 | SESE |
| K852998 | NEISSERIA - KWIK PLUS | Micro-Bio-Logics | Jul 23, 1985 | SESE |
| K852582 | GONI-KIT | Culture Kits, Inc. | Jul 12, 1985 | SESE |
| K833307 | PHADEBACK G.C. POSITIVE CONTROLS | Pharmacia, Inc. | Dec 27, 1983 | SESE |
| K833180 | GONOCHEK-II | E-Y Laboratories, Inc. | Nov 14, 1983 | SESE |
| K830364 | NEISSERIA IDENTIFICATION DISCS | Oxoid U.S.A., Inc. | Mar 8, 1983 | SESE |
| K812048 | IDS RAPIDS NH SYSTEMS | Carr-Scarborough Microbiologicals, Inc. | Aug 18, 1981 | SESE |
| K811412 | NEISSERIA-KWIK | Windsor Laboratories, Inc. | Jun 16, 1981 | SESE |
| P770002 | GONOCOCCAL PILI ANTIBODY TEST | Bioquest | Jul 18, 1979 | APWD |
| K782013 | GONO-CELL | Abbott Laboratories | Apr 23, 1979 | SESE |
| K781108 | MICROCULT-GC CULTURE TEST | Miles Laboratories, Inc. | Aug 31, 1978 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
- Analytical Products, Inc. — 1 clearance
- Austin Biological Laboratories — 1 clearance
- Bioquest — 1 clearance
- Carr-Scarborough Microbiologicals, Inc. — 1 clearance
