# K070206: Diagnostic Hybrids D3 Dfa Varicella-Zoster Virus Identification Kit, 01-020000

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Hybrids, Inc.
- Decided: Aug 30, 2007 after 220 days
- Product code: GQW (Antigen, Cf, (Including Cf Control), 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
Longest line of descent: 2 generations back to K951799 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951799: Varicella-Zoster Virus Direct Immunofluorescence Assay, Light Diagnostics (1996) Summary page 2.
- K990141: Light Diagnostics Simulfluor HSV/VZV Immunoflourescence Assay, Model 3295, Light Diagnostics (1999) Summary page 2.

## Indications for use
The Diagnostic Hybrids, Inc D3 DFA Varicella-zoster Virus Identification Kit is intended for use in the qualitative detection of varicella-zoster virus (VZV) in cell cultures by immunofluorescence using fluoresceinated monoclonal antibodies (MAbs). Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decision. Performance testing has not been done on direct patient specimen testing.

Source page: https://510kreport.com/device/K070206
Methodology: https://510kreport.com/methodology