# K020707: Ebv-Ebna Igg Elisa Kit, Model Ebg-100

- Pathway: 510(k) (Traditional)
- Applicant: Pan Bio Pty., Ltd.
- Decided: Jun 13, 2002 after 101 days
- Product code: GNP (Antiserum, Cf, 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) Incstar EBV-EBNA IgG ELISA: named in the summary without a submission number

## Indications for use
The Epstein Barr Virus Nuclear Antigen (EBNA) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBNA in serum as an aid in the diagnosis of Epstein Barr (EBV) infection in patients with clinical symptoms of infectious mononucleosis (IM). The PANBIO EBNA IgG ELISA should be used in conjunction with other EBV serologies.

Source page: https://510kreport.com/device/K020707
Methodology: https://510kreport.com/methodology