Panels › Microbiology › Product code LSE · Class 1
Epstein-Barr Virus, Other
Regulation 866.3235
2510(k)s in 12 months (58 all time)
1recalls in 12 months (7 all time)
5recalls that name a 510(k)
Top companies in LSE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2025 | GET TESTED INTERNATIONAL AB Epstein-Barr Virus (EBV VCA & EBNA IgG) Test Open, Classified |
LSE | None listed |
| Oct 20, 2014 | Diamedix Corporation Diamedix Is-EBV-VCA IgG Test Kit
Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Terminated |
LSE | K981812 |
| Apr 27, 2011 | Bio-Rad Laboratories BioPlex 2200 EBV IgG Calibrator Set. Catalog #663-1200.
Product is labeled in part: "BIO-RAD***BioPlex 2200 EBV IgG Calibrator Set***7 x 0.5 mL***A Calibrator set for the BioPlex 2200 EBV IgG Reagen Terminated |
LSE | K062211 |
| Mar 5, 2010 | Calbiotech Inc EBV VCA IgM ELISA 96 Well Kit, Catalog Number: EV012M
The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated |
LSE | None listed |
| Jun 11, 2008 | Bio-Rad Laboratories BIOPLEX 2200 EBV IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1350 - manufactured by Bio-Rad Laboratories in Redmond, WA. The product is a multiplex flow immunoassay intended for t Terminated |
LSE | K062213 |
| Jun 11, 2008 | Bio-Rad Laboratories BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100 tests - Catalog No. 665-1250 - manufactured by Bio-Rad Laboratories in Redmond, WA 98052. The product is multiflow immunoassay intended for th Terminated |
LSE | K062211 |
| Mar 29, 2005 | Diasorin Inc. DiaSorin ETI-EA-G assay kit Catalog No. 7570, lot # 113963C Terminated |
LSE | K992191 |
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