# K021793: Ebv EA-D Igg Elisa Kit, Model Ebg-100

- Pathway: 510(k) (Traditional)
- Applicant: Pan Bio Pty., Ltd.
- Decided: Sep 27, 2002 after 119 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) Trinity Biotech Captia™ EBV EA-D IgG ELISA: named in the summary without a submission number

## Indications for use
The Epstein Barr Virus Early Diffuse Antigen (EBV EA-D) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBV EA-D as an aid in the diagnosis of EBV infection in patients with clinical symptoms of Infectious Mononucleosis (IM). The PANBIO EBV EA-D IgG ELISA should be used in conjunction with other EBV serologies.

Source page: https://510kreport.com/device/K021793
Methodology: https://510kreport.com/methodology