LSW
8 FDA 510(k) clearances · Product code
120 daysmedian time to decision
349 days90th percentile
8clearances measured
FDA profile
- Official device name
- Anti-Dna Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1996: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 (K172348) | Aesku.Diagnostics GmbH & Co. KG | 2018-02-16 |
| QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls (K152013) | Inova Diagnostics, Inc. | 2016-04-11 |
| MODIFICATION TO AESKULISA DS DNA G (K081251) | Aesku Diagnostics | 2008-05-13 |
| ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 (K072393) | Phadia US, Inc. | 2007-12-07 |
| FIDIS DSDNA (K060380) | Biomedical Diagnostics (Bmd) SA | 2006-05-02 |
| AESKULISA DS DNA G (K041628) | Aesku Diagnostics | 2004-10-14 |
| ANTI-DSDNA ANTIBODY TEST (K921658) | Immco Diagnostics, Inc. | 1993-03-22 |
| THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS (K872085) | Immunodiagnostics, Ltd. | 1987-09-01 |
Track LSW automatically
Every clearance here is in the API, with alerts when new ones post.