# K081527: Light Diagnostics HSV 1/2 Typing Dfa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Millipore Corporation
- Decided: Apr 1, 2009 after 303 days
- Product code: GQL (Antisera, Fluorescent, Herpesvirus Hominis 1,2)
- Device class: 2
- Regulation: 21 CFR 866.3305
- 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) Cell Culture: named in the summary without a submission number

## Indications for use
The Light Diagnostics TM HSV 1/2 Typing DFA Kit is an in vitro diagnostic test for the qualitative detection and identification of herpes simplex virus type I and/or type 2 in direct specimens from patients with vesicular lesions and symptoms consistent with herpes infection and for culture confirmation by immunofluorescence. Negative results do not preclude an infection and should not be used as the sole basis for diagnosis, treatment or other management decisions. Specimens found negative on direct specimen detection should be confirmed by culture.

Source page: https://510kreport.com/device/K081527
Methodology: https://510kreport.com/methodology