# K983541: HSV 1+2 Igg Elisa Test

- Pathway: 510(k) (Traditional)
- Applicant: Gull Laboratories, Inc.
- Decided: Feb 26, 1999 after 140 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
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) HSV 142 IgG ELISA Test: named in the summary without a submission number
- (no number) HERPELISA II Test Kit: named in the summary without a submission number

## Indications for use
The HSV 142 IgG ELISA TEST is to be used manually or in conjunction with the Duet™ instrument in the testing of human serum specimens from individuals in whom the qualitative presence or absence of detectable IgG antibody to herpes simplex virus type 1 and type 2 is warranted in the determination of immunological experience pertaining to infection with herpes simplex virus type 1 and type 2 and as an aid in the diagnosis of herpes simplex virus associated disease.

Source page: https://510kreport.com/device/K983541
Methodology: https://510kreport.com/methodology