Home › MERIDIAN BIOSCIENCE, INC. › MERIFLUOR EBV-EA IgG IFA

MERIFLUOR EBV-EA IgG IFA

MERIDIAN BIOSCIENCE, INC. · Model EA101 · UDI-DI 00840733103247

LSE Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The MERIFLUOR EBV-EA IgG IFA Test is a sensitive and rapid immunofluorescence method for the qualitative and quantitative detection of antibodies to early antigen (EA) of Epstein-Barr virus (EBV) in human serum. When performed according to instructions, the MERIFLUOR EBV-EA IgG IFA Test detects IgG antibodies to the diffuse (D) and restricted (R) components of the EBV-EA complex. It is of value in providing supportive information for the diagnosis of EBV associated disease.

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Data 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.