# K963084: Opus CMV Test System-Modification

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Oct 9, 1996 after 62 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- 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) Abbott CMV Total AB EIA: named in the summary without a submission number

## Indications for use
OPUS® Anti CMV is a qualitative fluorogenic enzyme-linked immunosorbent assay (ELISA) used in the detection of total antibody to cytomegalovirus in human serum or heparin plasma to determine serological evidence of previous CMV infection. The OPUS Anti CMV assay is also intended for use to screen blood and/plasma donors to determine serological evidence of previous CMV infection. OPUS Anti CMV is intended for use with the OPUS analyzers.

Source page: https://510kreport.com/device/K963084
Methodology: https://510kreport.com/methodology