Kit, Screening, Staphylococcus Aureus
FDA product code JWX · Class I (low risk) · 21 CFR 866.2660 · Microbiology
20510(k) clearances
0PMA approvals
7recalls
Manufacturers
- American Micro Scan 1
- Binax, Inc. 1
- Oxoid , Ltd. 1
- Remel, L.P. 1
- Murex Diagnostics Limitd 1
- Trinity Laboratories, Inc. 1
- Biomerieux Vitek, Inc. 1
- Connecticut Diagnostics, Ltd. 1
- Orthomet, Inc. 1
- Ncs Diagnostics, Inc. 1
- Scott Laboratories, Inc. 1
- Texas Immunology, Inc. 1
- Advanced Medical Technology, Inc. 1
- Difco Laboratories, Inc. 1
- Immuno-Mycologics, Inc. 1
- Zeus Technologies 1
- Granite Diagnostics, Inc. 1
- Innovative Diagnostic Systems, Inc. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Dms Laboratories 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090964 | Binaxnox Staphylococcus Aureus TestJWX · Traditional | Binax, Inc. | 12/16/2009SE |
| K972030 | Staphytect Plus/Dryspot Staphytect PlusJWX · Traditional | Oxoid , Ltd. | 09/08/1997SE |
| K964315 | Remel Staph Latex KitJWX · Traditional | Remel, L.P. | 02/07/1997SE |
| K945538 | Staphaurex Plus(Tm)JWX · Traditional | Murex Diagnostics Limitd | 06/01/1995SE |
| K926173 | Staph-A-Lex(Tm) SystemJWX · Traditional | Trinity Laboratories, Inc. | 08/10/1993SE |
| K923212 | Slidex Staph-KitJWX · Traditional | Biomerieux Vitek, Inc. | 09/28/1992SE |
| K905617 | Visi-StaphJWX · Traditional | Connecticut Diagnostics, Ltd. | 03/29/1991SE |
| K902259 | Axiom Total Knee System, Tibial ComponentJWX · Traditional | Orthomet, Inc. | 06/18/1990SN |
| K874019 | StaphslideJWX · Traditional | Ncs Diagnostics, Inc. | 10/28/1987SE |
| K854278 | Neg Combo Breakpoint Panel Pos ComboJWX · Traditional | American Micro Scan | 03/04/1986SE |
| K855220 | V-Trend Kit Staph Latex TestJWX · Traditional | Texas Immunology, Inc. | 03/03/1986SE |
| K852997 | Rapi - StaphJWX · Traditional | Advanced Medical Technology, Inc. | 08/19/1985SE |
| K843560 | Bacto Staphylococcus Latex TestJWX · Traditional | Difco Laboratories, Inc. | 10/01/1984SE |
| K831918 | La-Staph Identification SystemJWX · Traditional | Immuno-Mycologics, Inc. | 06/08/1983SE |
| K830783 | Veri-StaphJWX · Traditional | Zeus Technologies | 04/08/1983SE |
| K822558 | LSM AgarJWX · Traditional | Granite Diagnostics, Inc. | 09/14/1982SE |
| K822144 | Ids Staphylochrome TestJWX · Traditional | Innovative Diagnostic Systems, Inc. | 08/24/1982SE |
| K821962 | BBL Staphyslide TestJWX · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/30/1982SE |
| K813614 | Staph TracJWX · Traditional | Dms Laboratories | 02/04/1982SE |
| K811098 | Sero-Stat Staphylococcus TestJWX · Traditional | Scott Laboratories, Inc. | 05/05/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0786-2023 Class II | API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500As the temperature and time out of range was exceeded, product performances cannot be guaranteed | Biomerieux Inc | 11/09/2022Open, Classified |
| Z-1045-2012 | SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell…Reports of false negative results in organism identification. | bioMerieux, Inc. | 12/21/2011Terminated |
| Z-1111-2010 | Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog…Unreactive Staph latex reagent | NERL Diagnostics Corporation | 01/15/2010Terminated |
| Z-1110-2010 | Lifesign Staph Latex Kits, 6 ml For In Vitro Diagnostic Use Catalog Number: 50051…Unreactive Staph latex reagent | NERL Diagnostics Corporation | 01/15/2010Terminated |
| Z-0818-2010 | Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and…The products may give false positive results with some non-Staphylococcus aureus strains | Remel, Inc | 07/20/2009Terminated |
| Z-0817-2010 | Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road…The products may give false positive results with some non-Staphylococcus aureus strains | Remel, Inc | 07/20/2009Terminated |
| Z-1008-2009 | Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination…Control and test wells are reversed on some of the reaction cards. | Remel, Inc | 10/07/2008Terminated |