# P050048: Monolisa Anti-HBS Eia

- Pathway: PMA
- Applicant: Bio-Rad Laboratories
- Decided: Aug 25, 2006 after 263 days
- Product code: SEI (Qualitative And Quantitative Hepatitis B Virus Antibody Assays)
- Device class: 2
- Regulation: 21 CFR 866.3173
- Recalls of this device: 2 (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 27, 2012 · Class II · Z-2398-2012: Prolonged exposure of the MONOLISA Anti-HBs EIA Conjugate Diluent component to light may result in elevated Optical Densities (OD) in some samples such that a negative sample could elevate to a grey z
- Aug 11, 2008 · Not classified · Z-1620-2010: The package insert provided with this kit contains a typographical error, giving incorrect directions to prepare a Working Conjugate Solution. If these directions are followed, it would result in a 1:

Source page: https://510kreport.com/device/P050048
Methodology: https://510kreport.com/methodology