Product code LSW
- Device name
- Anti-Dna Antibody, Antigen And Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5100
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 | Aesku.Diagnostics GmbH & Co. KG | 2018-02-16 |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | Inova Diagnostics, Inc. | 2016-04-11 |
| K081251 | MODIFICATION TO AESKULISA DS DNA G | Aesku Diagnostics | 2008-05-13 |
| K072393 | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 | Phadia US, Inc. | 2007-12-07 |
| K060380 | FIDIS DSDNA | Biomedical Diagnostics (Bmd) SA | 2006-05-02 |
| K041628 | AESKULISA DS DNA G | Aesku Diagnostics | 2004-10-14 |
| K921658 | ANTI-DSDNA ANTIBODY TEST | Immco Diagnostics, Inc. | 1993-03-22 |
| K872085 | THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS | Immunodiagnostics, Ltd. | 1987-09-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04250289513401 | AESKUSLIDES® nDNA (Crithidia luciliae) | Aesku.Diagnostics GmbH & Co. KG | 2024-11-15 |
| 08430793040051 | Aptiva® CTD Essential Reagent | INOVA DIAGNOSTICS, INC. | 2023-12-14 |
| 00894175000237 | AccuDiag ™ | Diagnostic Automation, Inc. | 2021-08-06 |
| 07333066019406 | EliA dsDNA Well | Phadia AB | 2019-03-06 |
| 07333066010557 | EliA dsDNA Well | Phadia AB | 2019-03-06 |
| 04250289510394 | AESKUSLIDES nDNA (Crithidia luciliae) | Aesku.Diagnostics GmbH & Co. KG | 2018-05-14 |
| 04250289503037 | AESKULISA® dsDNA-G | Aesku.Diagnostics GmbH & Co. KG | 2017-03-17 |
| 04250289503440 | AESKULISA® dsDNA G | Aesku.Diagnostics GmbH & Co. KG | 2017-02-28 |
| B24235DSGHUE010 | Anti-ds-DNA-G ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2017-01-18 |
| 04250289500647 | AESKULISA® dsDNA-G | Aesku.Diagnostics GmbH & Co. KG | 2016-09-27 |
| 08426950624646 | QUANTA Flash® dsDNA Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |
| 08426950627760 | QUANTA Flash® dsDNA Reagents | INOVA DIAGNOSTICS, INC. | 2016-08-31 |