Panels › Microbiology › Product code JWX · Class 1
Kit, Screening, Staphylococcus Aureus
Regulation 866.2660
0510(k)s in 12 months (20 all time)
0recalls in 12 months (7 all time)
2recalls that name a 510(k)
Top companies in JWX
| Company | 510(k)s | Recalls |
|---|---|---|
| Remel, L.P. | 1 | 3 |
| Biomerieux Inc | 0 | 2 |
| NERL Diagnostics Corporation | 0 | 2 |
| Advanced Medical Technology, Inc. | 1 | 0 |
| American Micro Scan | 1 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 1 | 0 |
| Binax, Inc. | 1 | 0 |
| Biomerieux Vitek, Inc. | 1 | 0 |
| Connecticut Diagnostics, Ltd. | 1 | 0 |
| Difco Laboratories, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2023 | Biomerieux Inc API STAPH 25 STRIPS+25 MEDIA, CATALOG 20500 Open, Classified |
JWX | None listed |
| Feb 16, 2012 | bioMerieux, Inc. SLIDEX Staph kit (250 Tests).
The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media. Terminated |
JWX | K923212 |
| Mar 12, 2010 | NERL Diagnostics Corporation Wampole Staph Latex Test, 6.0 ml -120 Test Kit
For In Vitro Diagnostic Use
Catalog Number: 56D6
Manufactured for; Wampole Laboratories Cranbury, New Jersey 08512
A rapid latex agglutination test t Terminated |
JWX | None listed |
| Mar 12, 2010 | NERL Diagnostics Corporation Lifesign Staph Latex Kits, 6 ml
For In Vitro Diagnostic Use
Catalog Number: 50051
Manufactured for Lifesign LLC , Somerset, NJ 08873
A rapid latex agglutination test to detect Protein A and/or clump Terminated |
JWX | None listed |
| Feb 23, 2010 | Remel, Inc Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Oxoid Ltd., Wade Road, Basingstoke, Hants UK.
Latex slide agglutination test for the diff Terminated |
JWX | None listed |
| Feb 23, 2010 | Remel, Inc Oxoid dry Spot Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Oxoid Ltd., Wade road, Basingstoke, Hants, UK.
Latex slide agglutination test for the differentiation of staphylococcus aureus by det Terminated |
JWX | None listed |
| Mar 20, 2009 | Remel, Inc Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit.
Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain po Terminated |
JWX | K972030 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.