# K954920: Murex Rub-EX

- Pathway: 510(k) (Traditional)
- Applicant: Murex Diagnostics, Inc.
- Decided: Aug 21, 1996 after 300 days
- Product code: LQN (Latex Agglutination Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) Rubascan: named in the summary without a submission number
- (no number) Rubalex: named in the summary without a submission number

## Indications for use
The Murex Rib-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum.

Source page: https://510kreport.com/device/K954920
Methodology: https://510kreport.com/methodology