# P060031: Bio-Rad Monolisa Anti-HBC Eia

- Pathway: PMA
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Apr 27, 2007 after 179 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
- Jan 7, 2008 · Not classified · Z-1189-2008: Incorrect result: Elevated reactivity with a kit lot 232BGG. Patient samples that are negative for antibodies to anti-HBc could be assigned a positive result.

Source page: https://510kreport.com/device/P060031
Methodology: https://510kreport.com/methodology