Panels › Microbiology › Product code LJY · Class 1
Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Regulation 866.3380
0510(k)s in 12 months (8 all time)
0recalls in 12 months (7 all time)
5recalls that name a 510(k)
Top companies in LJY
| Company | 510(k)s | Recalls |
|---|---|---|
| Diamedix Corporation | 0 | 2 |
| Zeus Scientific, Inc. | 1 | 1 |
| bioMerieux, Inc. | 0 | 1 |
| Biomerieux Vitek, Inc. | 1 | 0 |
| Bion Enterprises Ltd | 0 | 1 |
| Biowhittaker Molecular Applications, Inc. | 1 | 0 |
| Calbiotech Inc | 0 | 1 |
| Columbia Bioscience, Inc. | 1 | 0 |
| Diasorin Inc. | 0 | 1 |
| Gull Laboratories, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2021 | bioMerieux, Inc. VIDAS Mumps IgG (MPG), REF 30218 Open, Classified |
LJY | None listed |
| Jan 5, 2018 | Diamedix Corporation Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540 Terminated |
LJY | K991274 |
| Oct 20, 2014 | Diamedix Corporation Diamedix Is-Mumps 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 M Terminated |
LJY | K991274 |
| Jun 5, 2013 | Bion Enterprises Ltd Plastic bottle containing 3.5 mL of IgG FITC Conjugate
Product Usage:
Product is a used as a counterstain for various indirect fluorescent assay kits Terminated |
LJY | K926066 |
| May 8, 2012 | Zeus Scientific, Inc. AtheNA Multi-Lyte MMV Test System- A93111G
A microparticle-based immunoassay intended for the qualitative presumptive detection of IgG class antibody to the Mumps virus in human serum using the AtheN Terminated |
LJY | K961204 |
| Mar 5, 2010 | Calbiotech Inc Mumps IgM ELISA 96 Well Kit, Catalog Number: MP060G
The products in question are all Enzyme Linked Immunosorbent Assay (ELISA) Test kits designed and marketed for Research Use Only. Terminated |
LJY | None listed |
| Feb 23, 2006 | Diasorin Inc. The ETI-Mumps IgG Enzyme Immunoassay Test Kit is sold with assay software version 1.0. that is designed to work exclusively with the ETI-Max 3000 automated platform (version 1.51.1). Terminated |
LJY | K991274 |
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