# K991975: Seraquest EB NA Igg

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Nov 2, 1999 after 144 days
- Product code: LSE (Epstein-Barr Virus, Other)
- Device class: 1
- Regulation: 21 CFR 866.3235
- 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) Gull Laboratories' EBNA IgG ELISA test: named in the summary without a submission number

## Indications for use
For in vitro diagnostic use only. For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr virus nuclear antigen in human serum by enzyme immunoassay. May be used in conjunction with other EBV serologicals as an aid in the diagnosis of infectious mononucleosis.

Source page: https://510kreport.com/device/K991975
Methodology: https://510kreport.com/methodology