# K954301: Abbott CMV Total Antibody Eia (Modification)

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 24, 1997 after 579 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) CETUS Cytomegalovirus Indirect Hemagglutination Assay (IHA): named in the summary without a submission number

## Indications for use
Both are intended for use in the detection of antibody to CMV.

Source page: https://510kreport.com/device/K954301
Methodology: https://510kreport.com/methodology