# K951821: Cytomegalovirus Direct Immunofluorescence Assay

- Pathway: 510(k) (Traditional)
- Applicant: Light Diagnostics
- Decided: Jun 7, 1996 after 414 days
- Product code: LIN (Antisera, Conjugated Fluorescent, 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Light Diagnostics Cytomegalovirus Immunofluorescence Assay: named in the summary without a submission number
- (no number) Cytomegalovirus Pre-CPE Culture Identification Test: named in the summary without a submission number
- (no number) Syva MicroTrak CMV Culture Identification Test For pre-CPE and CPE applications: named in the summary without a submission number

## Most influential descendants
- K081164: D3 Dfa Cytomegalovirus Immediate Early Antigen Identification Kit (2008), 0 descendants of its own

## Indications for use
The Light Diagnostics Cytomegalovirus Direct Immunofluorescence Assay is intended for use in centrifugation enhanced shell vials in the qualitative detection and identification of immediate early antigen- of human CMV.

Source page: https://510kreport.com/device/K951821
Methodology: https://510kreport.com/methodology