# K061239: Euroimmun Anti-HSV-2 Elisa (Igg) and Anti-HSV-1 Elisa (Igg) Kit

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, LLC
- Decided: Jun 28, 2007 after 421 days
- Product code: MYF (Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EUROIMMUN Anti-HSV-1 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against Herpes simplex virus type 1 (HSV-1) specific glycoprotein C1 in human serum. It is intended for the presumptive diagnosis of type specific HSV-1 infection in conjunction with EUROIMMUN Anti-HSV-2 ELISA (IgG) in persons suspected of herpes viral infection. The EUROIMMUN Anti-HSV-2 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against herpes simplex virus type 2 (HSV-2) specific glycoprotein G2 in human serum. It is intended for the presumptive diagnosis of type specific HSV-2 infection in conjunction with EUROIMMUN Anti-HSV-1 ELISA (IgG) in persons suspected of herpes viral infection.

Source page: https://510kreport.com/device/K061239
Methodology: https://510kreport.com/methodology