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EBV-EA IgG ELISA
DRG International Inc · Model EIA-2796 · UDI-DI 00840239027962
LSE
Prescription
1
510(k) clearances
4
Adverse events
7
Recalls
15
Facilities
Description
The DRG Epstein Barr Virus Early Antigen (EBV-EA) IgG ELISA test system provides a means for the qualitative detection of IgG class antibodies to Epstein-Barr Virus (EBV) Early Antigen (EA) in human sera. This test is intended to aid in the diagnosis of infectious mononucleosis (IM) when used with other EBV serological tests. The performance characteristics have not been established to aid in the diagnosis of acute IM.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2014-10-20 | Diamedix Corporation | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. |
| 2011-03-11 | Bio-Rad Laboratories | Bio-Rad Laboratories confirmed a downward shift in control values for EBV NA-1 analyte when using the BioPlex 2200 EBV IgG Calibrator Set Lot #46704. |
| 2008-08-27 | Calbiotech Inc | The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA kits. Although there is no potential health hazard related to this recall, |
| 2007-11-13 | Bio-Rad Laboratories | False negative results due to reagent packs exhibiting low signal. |
| 2007-11-13 | Bio-Rad Laboratories | False negative results due to reagent packs exhibiting low signal. |
| 2004-11-01 | Diasorin Inc. | The DiaSorin ETI-EA-G kits contained the wrong microtiter plate. The plate provided in the kits was for a different product, the ProTrac II Tacrolimus kit. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.