Product code JWX
- Device name
- Kit, Screening, Staphylococcus Aureus
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K090964 | BINAXNOX STAPHYLOCOCCUS AUREUS TEST | Binax, Inc. | 2009-12-16 |
| K972030 | STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS | Oxoid , Ltd. | 1997-09-08 |
| K964315 | REMEL STAPH LATEX KIT | Remel, L.P. | 1997-02-07 |
| K945538 | STAPHAUREX PLUS(TM) | Murex Diagnostics Limitd | 1995-06-01 |
| K926173 | STAPH-A-LEX(TM) SYSTEM | Trinity Laboratories, Inc. | 1993-08-10 |
| K923212 | SLIDEX STAPH-KIT | Biomerieux Vitek, Inc. | 1992-09-28 |
| K905617 | VISI-STAPH | Connecticut Diagnostics, Ltd. | 1991-03-29 |
| K902259 | AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT | Orthomet, Inc. | 1990-06-18 |
| K874019 | STAPHSLIDE | Ncs Diagnostics, Inc. | 1987-10-28 |
| K854278 | NEG COMBO BREAKPOINT PANEL POS COMBO | American Micro Scan | 1986-03-04 |
| K855220 | V-TREND KIT STAPH LATEX TEST | Texas Immunology, Inc. | 1986-03-03 |
| K852997 | RAPI - STAPH | Advanced Medical Technology, Inc. | 1985-08-19 |
| K843560 | BACTO STAPHYLOCOCCUS LATEX TEST | Difco Laboratories, Inc. | 1984-10-01 |
| K831918 | LA-STAPH IDENTIFICATION SYSTEM | Immuno-Mycologics, Inc. | 1983-06-08 |
| K830783 | VERI-STAPH | Zeus Technologies | 1983-04-08 |
| K822558 | LSM AGAR | Granite Diagnostics, Inc. | 1982-09-14 |
| K822144 | IDS STAPHYLOCHROME TEST | Innovative Diagnostic Systems, Inc. | 1982-08-24 |
| K821962 | BBL STAPHYSLIDE TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-07-30 |
| K813614 | STAPH TRAC | Dms Laboratories | 1982-02-04 |
| K811098 | SERO-STAT STAPHYLOCOCCUS TEST | Scott Laboratories, Inc. | 1981-05-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05032384029044 | STAPHYTECT PLUS | OXOID LIMITED | 2026-01-28 |
| 05032384029051 | STAPHYTECT PLUS | OXOID LIMITED | 2026-01-28 |
| 00816057021826 | ASI Color Staph Latex Test | ARLINGTON SCIENTIFIC, INC. | 2023-12-19 |
| 00816057021833 | ASI Color Staph Latex Test | ARLINGTON SCIENTIFIC, INC. | 2023-12-19 |
| 00816057021840 | ASI Color Staph Latex Test | ARLINGTON SCIENTIFIC, INC. | 2023-12-19 |
| 00848838023002 | Remel | REMEL, INC. | 2021-11-12 |
| 30848838022983 | Remel | REMEL, INC. | 2021-11-12 |
| 30848838023003 | Remel | REMEL, INC. | 2021-11-12 |
| 03848838022989 | Remel | REMEL, INC. | 2021-11-12 |
| 03848838023009 | Remel | REMEL, INC. | 2021-11-12 |
| 00848838022982 | Remel | REMEL, INC. | 2021-11-12 |
| 05056080501512 | Staphaurex Plus (150 test) | REMEL EUROPE LIMITED | 2021-07-21 |
| 05056080501529 | Staphaurex Plus (450 test) | REMEL EUROPE LIMITED | 2021-07-21 |
| 03573026588601 | ID 32 STAPH | BIOMERIEUX SA | 2020-04-10 |
| 03573026048259 | API® Staph | BIOMERIEUX SA | 2020-04-10 |
| 03573026066499 | ID 32 STAPH | BIOMERIEUX SA | 2020-04-10 |
| 20885380020176 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 20885380020237 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2016-09-15 |
| 00816057020065 | ASI Staphslide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020072 | ASI Staphslide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020089 | ASI Staphslide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020096 | ASI Staphslide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020102 | ASI Staphslide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057020119 | ASI Staphslide Test | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |
| 00816057021581 | ASI Staphslide Control Set | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |