# P970054: Biotrin Parvovirus B19 Igg

- Pathway: PMA
- Applicant: Diasorin
- Decided: Aug 6, 1999 after 708 days
- Product code: MYL (Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igg)
- 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
- Jul 17, 2020 · Class II · Z-2936-2020: Printed label inside the box lid of the Parvovirus has the incorrect Lot Specific Constant value

Source page: https://510kreport.com/device/P970054
Methodology: https://510kreport.com/methodology