# K951799: Varicella-Zoster Virus Direct Immunofluorescence Assay

- Pathway: 510(k) (Traditional)
- Applicant: Light Diagnostics
- Decided: Mar 20, 1996 after 336 days
- Product code: GQX (Antiserum, Cf, Varicella-Zoster)
- Device class: 2
- Regulation: 21 CFR 866.3900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) Meridian Diagnostics, Inc. Merifluor VZV: named in the summary without a submission number

## Most influential descendants
- K990141: Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model 3295 (1999), 1 descendant of its own
- K070206: Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000 (2007), 0 descendants of its own

## Indications for use
Light Diagnostics Varicella-zoster virus Direct Immunofluorescence Assay is intended for in vitro diagnostic use in the qualitative detection of VZV from vesicular smears and in cell culture viral isolation and confirmation.

Source page: https://510kreport.com/device/K951799
Methodology: https://510kreport.com/methodology