# K971857: Mumps Igg Elisa Testy

- Pathway: 510(k) (Traditional)
- Applicant: Gull Laboratories, Inc.
- Decided: Nov 4, 1997 after 168 days
- Product code: LJY (Enzyme Linked Immunoabsorbent Assay, Mumps Virus)
- Device class: 1
- Regulation: 21 CFR 866.3380
- 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) Mumps Stat Test Kit / BioWhittaker, Inc.: named in the summary without a submission number

## Indications for use
The MUMPS IgG ELISA TEST is to be used in the testing of human serum specimens from asymptomatic and symptomatic children and adults for whom quantitation of the presence or the qualitative presence or absence of detectable IgG antibody to mumps virus is warranted in the determination of immunological experience pertaining to infection with mumps virus and as an aid in the diagnosis of mumps infection.

Source page: https://510kreport.com/device/K971857
Methodology: https://510kreport.com/methodology