# P150042: Zeus Elisa Parvovirus B19 Igm Test System

- Pathway: PMA
- Applicant: Zeus Scientific, Inc.
- Decided: Sep 19, 2017 after 670 days
- Product code: MYM (Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm)
- Device class: 3
- 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
- Oct 31, 2023 · Class II · Z-0603-2024: The organization completed a product improvement process to the conjugate found within the certain ELISA kits. This modification was not reviewed and approved by FDA prior to its implementation.

Source page: https://510kreport.com/device/P150042
Methodology: https://510kreport.com/methodology