Home › Device types › LSE
Epstein-Barr Virus, Other
FDA product code LSE · Class 1 · Microbiology
41
Registered devices
4
Adverse events
7
Recalls
56
510(k) clearances
Devices with this code
EBV-EA IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungBio-Rad Laboratories — Bio-RAD Laboratories, Inc.Gold Standard Diagnostics Is-EBV-EA-D IgM Test Kit — Gold Standard Diagnostics CorporationTrinity Biotech — CLARK LABORATORIES, INC.ASI EBNA IgG EIA Test — ARLINGTON SCIENTIFIC, INC.EBV-EA IgG ELISA — DRG International IncBioPlex 2200 — BIO-RAD LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.EBV EA 10 Well; 10 pk — SCIMEDX CORPORATIONGold Standard Diagnostics Is-EBV-VCA IgM Test Kit — Gold Standard Diagnostics CorporationSeraQuest — QUEST INTERNATIONAL, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.ReQuest — QUEST INTERNATIONAL, INC.Bio-Rad — Bio-RAD Laboratories, Inc.EBV-EA IgG 120 Test Kit — SCIMEDX CORPORATIONDiamedix — DIAMEDIX CORPORATIONBio-Rad Platelia — CLARK LABORATORIES, INC.Diamedix — DIAMEDIX CORPORATIONBioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Bio-Rad Platelia — CLARK LABORATORIES, INC.Epstein Barr Virus VCA IgM ELISA — DRG International IncDiamedix — DIAMEDIX CORPORATIONBio-Rad Laboratories — Bio-RAD Laboratories, Inc.
Recent 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 rel |
| 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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