Panels › Immunology › Product code LSW · Class 2
Anti-Dna Antibody, Antigen And Control
Regulation 866.5100
0510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in LSW
| Company | 510(k)s | Recalls |
|---|---|---|
| Aesku Diagnostics | 3 | 0 |
| Phadia US, Inc. | 1 | 1 |
| Biomedical Diagnostics (Bmd) SA | 1 | 0 |
| Immco Diagnostics, Inc. | 1 | 0 |
| Immunodiagnostics, Ltd. | 1 | 0 |
| Inova Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 16, 2018 | K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia lucil Aesku.Diagnostics GmbH & Co. KG, DE | LSW |
| Apr 11, 2016 | K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls Inova Diagnostics, Inc. | LSW |
| May 13, 2008 | K081251 | MODIFICATION TO AESKULISA DS DNA G Aesku Diagnostics, DE | LSW |
| Dec 7, 2007 | K072393 | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 Phadia US, Inc. | LSW |
| May 2, 2006 | K060380 | FIDIS DSDNA Biomedical Diagnostics (Bmd) SA, FR | LSW |
| Oct 14, 2004 | K041628 | AESKULISA DS DNA G Aesku Diagnostics | LSW |
| Mar 22, 1993 | K921658 | ANTI-DSDNA ANTIBODY TEST Immco Diagnostics, Inc. | LSW |
| Sep 1, 1987 | K872085 | THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS Immunodiagnostics, Ltd., GB | LSW |
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