Home › Device types › LJY
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
FDA product code LJY · Class 1 · Microbiology
33
Registered devices
7
Adverse events
7
Recalls
8
510(k) clearances
Devices with this code
BioPlex 2200 — BIO-RAD LABORATORIES, INC.Anti-Mumps Virus AT ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGBio-Rad Laboratories — Bio-RAD Laboratories, Inc.SeraQuest — QUEST INTERNATIONAL, INC.NovaLisa Mumps Virus IgG — Gold Standard Diagnostics Frankfurt GmbHGold Standard Diagnostics Is-Mumps IgG ELISA Test Kit — Gold Standard Diagnostics CorporationReQuest — QUEST INTERNATIONAL, INC.Mumps IgM ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungBioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.Anti-Mumps Virus ELISA (G5) (IgM) — EUROIMMUN Medizinische Labordiagnostika AGTrinity Biotech — CLARK LABORATORIES, INC.Mumps Virus IgG ELISA — DRG International IncBioPlex 2200 — BIO-RAD LABORATORIES, INC.Mumps IgM ELISA — DRG International IncBioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.VIDAS® Mumps IgG — BIOMERIEUX SASeraQuest — QUEST INTERNATIONAL, INC.Anti-Mumps Virus ELISA (IgG) — EUROIMMUN Medizinische Labordiagnostika AGTrinity Biotech — CLARK LABORATORIES, INC.Anti-Mumps Virus ELISA (IgM) — EUROIMMUN Medizinische Labordiagnostika AGReQuest — QUEST INTERNATIONAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2018-01-05 | Diamedix Corporation | Contains a gel-like contaminant that may affect product performance. |
| 2014-10-20 | Diamedix Corporation | A gel-like substance was found in kit component, sample diluent , that could potentially compromise product performance. |
| 2013-01-23 | Bion Enterprises Ltd | Affected products have a labeled expiration date of one year too long. |
| 2012-03-08 | Zeus Scientific, Inc. | Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results in seronegative patients who have not been previous |
| 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 |
| 2005-08-08 | Diasorin Inc. | Potential for false negative results. A software anomaly may occur when performing the ETI-Mumps IgG assay on the ETI-Max 3000 automated platform. The error oc |
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