# K950670: Immulite Herpes I and II Igg

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Jun 21, 1996 after 494 days
- Product code: LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific)
- 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
Longest line of descent: 1 generation back to K822883 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822883: Herpelisa Kit, M.A. Bioproducts (1983) Summary page 1.

## Indications for use
IMMULITE Herpes I & II IgG is designed for the qualitative detection of IgG antibodies to herpes simplex virus (HSV) type I & II in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of serological status to HSV I & II.

Source page: https://510kreport.com/device/K950670
Methodology: https://510kreport.com/methodology