# P060034: Bio Rad Monolisa Anti-HBC Igm Eia

- Pathway: PMA
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: May 31, 2007 after 190 days
- Product code: SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays)
- Device class: 2
- Regulation: 21 CFR 866.3173
- 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
- Sep 5, 2007 · Not classified · Z-0065-2008: Incorrect Instruction: the package insert states to add 100L of conjugate; it should state to add 100uL.

Source page: https://510kreport.com/device/P060034
Methodology: https://510kreport.com/methodology