# P990042: Diasorin Eti-AB-Auk Plus Assay

- Pathway: PMA
- Applicant: DiaSorin, Inc.
- Decided: Mar 30, 2001 after 637 days
- Device class: III
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Aug 19, 2010 · Not classified · Z-1744-2011: Through internal testing, DiaSorin has become aware that the kit lots identified (ETI-AB-AUK PLUS kits, catalog number P001931, lot numbers 0650270A and/or 0650270A/1) may not consistently exhibit sta

Source page: https://510kreport.com/device/P990042
Methodology: https://510kreport.com/methodology