JWX · Kit, Screening, Staphylococcus Aureus
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JWX |
|---|---|
| Device Name | Kit, Screening, Staphylococcus Aureus |
| 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 (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K090964 | BINAXNOX STAPHYLOCOCCUS AUREUS TEST | Binax, Inc. | Dec 16, 2009 | SESE |
| K972030 | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS | Oxoid , Ltd. | Sep 8, 1997 | SESE |
| K964315 | REMEL STAPH LATEX KIT | Remel, L.P. | Feb 7, 1997 | SESE |
| K945538 | STAPHAUREX PLUS(TM) | Murex Diagnostics Limitd | Jun 1, 1995 | SESE |
| K926173 | STAPH-A-LEX(TM) SYSTEM | Trinity Laboratories, Inc. | Aug 10, 1993 | SESE |
| K923212 | SLIDEX STAPH-KIT | Biomerieux Vitek, Inc. | Sep 28, 1992 | SESE |
| K905617 | VISI-STAPH | Connecticut Diagnostics, Ltd. | Mar 29, 1991 | SESE |
| K902259 | AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT | Orthomet, Inc. | Jun 18, 1990 | SN |
| K874019 | STAPHSLIDE | Ncs Diagnostics, Inc. | Oct 28, 1987 | SESE |
| K854278 | NEG COMBO BREAKPOINT PANEL POS COMBO | American Micro Scan | Mar 4, 1986 | SESE |
| K855220 | V-TREND KIT STAPH LATEX TEST | Texas Immunology, Inc. | Mar 3, 1986 | SESE |
| K852997 | RAPI - STAPH | Advanced Medical Technology, Inc. | Aug 19, 1985 | SESE |
| K843560 | BACTO STAPHYLOCOCCUS LATEX TEST | Difco Laboratories, Inc. | Oct 1, 1984 | SESE |
| K831918 | LA-STAPH IDENTIFICATION SYSTEM | Immuno-Mycologics, Inc. | Jun 8, 1983 | SESE |
| K830783 | VERI-STAPH | Zeus Technologies | Apr 8, 1983 | SESE |
| K822558 | LSM AGAR | Granite Diagnostics, Inc. | Sep 14, 1982 | SESE |
| K822144 | IDS STAPHYLOCHROME TEST | Innovative Diagnostic Systems, Inc. | Aug 24, 1982 | SESE |
| K821962 | BBL STAPHYSLIDE TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jul 30, 1982 | SESE |
| K813614 | STAPH TRAC | Dms Laboratories | Feb 4, 1982 | SESE |
| K811098 | SERO-STAT STAPHYLOCOCCUS TEST | Scott Laboratories, Inc. | May 5, 1981 | SESE |
Top Applicants
- Advanced Medical Technology, Inc. — 1 clearance
- American Micro Scan — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Binax, Inc. — 1 clearance
- Biomerieux Vitek, Inc. — 1 clearance
