# K973941: Immunowell Ebna Igg Test

- Pathway: 510(k) (Traditional)
- Applicant: Genbio
- Decided: Aug 10, 1998 after 299 days
- Product code: LLM (Test, Antigen, Nuclear, Epstein-Barr Virus)
- 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) Epstein-Barr Nuclear Antigen (EBNA) IgG ELISA Kit, Gull Laboratories, Inc.: named in the summary without a submission number

## Indications for use
ImmunoWELL EBNA IgG Test is for the qualitative detection of IgG antibody to Epstein-Barr Virus nuclear antigen-1 (EBNA-1) in human serum by ELISA. When the EBNA IgG test is used in conjunction with other testing such as the EBV viral capsid IgG or IgM, EBV early antigen IgG tests andjor heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM) and the stage of EBV infection in adults and children.

Source page: https://510kreport.com/device/K973941
Methodology: https://510kreport.com/methodology