Enzyme Linked Immunoabsorbent Assay, Mumps Virus
FDA product code LJY · Class I (low risk) · 21 CFR 866.3380 · Microbiology
8510(k) clearances
0PMA approvals
6recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991274 | Mumps Igg Elisa Test SystemLJY · Traditional | Columbia Bioscience, Inc. | 09/03/1999SE |
| K980059 | Seraquest Mumps IggLJY · Traditional | Quest Intl., Inc. | 04/23/1998SE |
| K971857 | Mumps Igg Elisa TestyLJY · Traditional | Gull Laboratories, Inc. | 11/04/1997SE |
| K961204 | Mumps Igg TestLJY · Traditional | Zeus Scientific, Inc. | 07/18/1996SE |
| K925209 | Mumps StatLJY · Traditional | Biowhittaker Molecular Applications, Inc. | 10/14/1994SE |
| K923903 | Vitek Immunodiagnostic Assay System Mumps Igg AssaLJY · Traditional | Biomerieux Vitek, Inc. | 08/09/1993SE |
| K897006 | Pharmacia Mumps Igg ElisaLJY · Traditional | Pharmacia Eni Diagnostics, Inc. | 07/26/1990SE |
| K830045 | Mumpselisa Test KitLJY · Traditional | M.A. Bioproducts | 05/13/1983SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0429-2022 Class II | VIDAS Mumps IgG (MPG), REF 30218bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It… | bioMerieux, Inc. | 09/22/2021Open, Classified |
| Z-2573-2018 Class III | Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog…Contains a gel-like contaminant that may affect product performance. | Diamedix Corporation | 01/05/2018Terminated |
| Z-1685-2016 Class II | Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure…A gel-like substance was found in kit component, sample diluent , that could potentially compromise product… | Diamedix Corporation | 10/20/2014Terminated |
| Z-1479-2013 Class III | Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used…Affected products have a labeled expiration date of one year too long. | Bion Enterprises Ltd | 01/23/2013Terminated |
| Z-1500-2012 | AtheNA Multi-Lyte MMV Test System- A93111G A microparticle-based immunoassay intended…Select lots of AtheNA Multi-Lyte MMV Test System have lost reactivity and may produce false positive results… | Zeus Scientific, Inc. | 03/08/2012Terminated |
| Z-0999-2010 | Mumps IgM ELISA 96 Well Kit, Catalog Number: MP060G The products in question are all…The recall has been initiated due to the "For Export Only" labeling found on some Calbiotech, Inc. ELISA… | Calbiotech Inc | 08/27/2008Terminated |