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Kit, Screening, Staphylococcus Aureus
FDA product code JWX · Class 1 · Microbiology
20
Registered devices
12
Adverse events
7
Recalls
20
510(k) clearances
Devices with this code
ASI Color Staph Latex Test — ARLINGTON SCIENTIFIC, INC.ASI Staphslide Test — ARLINGTON SCIENTIFIC, INC.Remel — REMEL, INC.ASI Staphslide Test — ARLINGTON SCIENTIFIC, INC.API® Staph — BIOMERIEUX SACARDINAL HEALTH — Cardinal Health 200, LLCASI Staphslide Test — ARLINGTON SCIENTIFIC, INC.CARDINAL HEALTH — Cardinal Health 200, LLCSTAPHYTECT PLUS — OXOID LIMITEDASI Staphslide Control Set — ARLINGTON SCIENTIFIC, INC.ID 32 STAPH — BIOMERIEUX SASTAPHYTECT PLUS — OXOID LIMITEDASI Staphslide Test — ARLINGTON SCIENTIFIC, INC.ASI Staphslide Test — ARLINGTON SCIENTIFIC, INC.ASI Staphslide Test — ARLINGTON SCIENTIFIC, INC.ASI Color Staph Latex Test — ARLINGTON SCIENTIFIC, INC.Staphaurex Plus (450 test) — REMEL EUROPE LIMITEDRemel — REMEL, INC.Staphaurex Plus (150 test) — REMEL EUROPE LIMITEDASI Color Staph Latex Test — ARLINGTON SCIENTIFIC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-11-09 | Biomerieux Inc | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| 2011-12-21 | bioMerieux, Inc. | Reports of false negative results in organism identification. |
| 2010-01-15 | NERL Diagnostics Corporation | Unreactive Staph latex reagent |
| 2010-01-15 | NERL Diagnostics Corporation | Unreactive Staph latex reagent |
| 2009-07-20 | Remel, Inc | The products may give false positive results with some non-Staphylococcus aureus strains |
| 2009-07-20 | Remel, Inc | The products may give false positive results with some non-Staphylococcus aureus strains |
| 2008-10-07 | Remel, Inc | Control and test wells are reversed on some of the reaction cards. |
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