Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
No recalls linked.
Regulatory clearances
- 510(k)K172348Substantially equivalent (SESE) · 2018-02-16clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2017-03-02 | VAI | Voluntary action indicated | Aesku Group GmbH & Co. KG | 2 |
Similar devices
- AccuDiag ™ Diagnostic Automation, Inc.
- Anti-ds-DNA-G ELISA AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
- Aptiva® CTD Essential Reagent INOVA DIAGNOSTICS, INC.
- EliA dsDNA Well Phadia AB
- QUANTA Flash® dsDNA Reagents INOVA DIAGNOSTICS, INC.
- QUANTA Flash® dsDNA Reagents INOVA DIAGNOSTICS, INC.
- AESKULISA® dsDNA G Aesku.Diagnostics GmbH & Co. KG (same company)
- AESKULISA® dsDNA-G Aesku.Diagnostics GmbH & Co. KG (same company)
- AESKULISA® dsDNA-G Aesku.Diagnostics GmbH & Co. KG (same company)
- AESKUSLIDES nDNA (Crithidia luciliae) Aesku.Diagnostics GmbH & Co. KG (same company)
Select up to two to place side-by-side with this device.