Antigen, Iha, Cytomegalovirus
FDA product code LJO · Class II (moderate risk) · 21 CFR 866.3175 · Microbiology
12510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203612 | Capture-CMVLJO · Traditional | Immucor, Inc. | 03/22/2021SE |
| K183571 | Capture-CMVLJO · Traditional | Immucor, Inc. | 02/04/2019SE |
| K001767 | Diamedix Is-Cmv Igm Capture Test SystemLJO · Traditional | Diamedix Corp. | 08/07/2000SE |
| K974901 | Hybrid Capture System CMV DNA AssayLJO · Traditional | Digene Corp. | 09/29/1998SE |
| K974456 | CmvgenLJO · Traditional | Instrumentation Laboratory CO | 05/01/1998SE |
| K951851 | Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayLJO · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 07/24/1996SE |
| K955799 | Copalis CMV Total Antibody AssayLJO · Traditional | Sienna Biotech, Inc. | 07/10/1996SE |
| K920222 | Healthtest Assay for Antibody to CytomegalovirusLJO · Traditional | Akers Research Corp. | 07/27/1992SE |
| K910003 | Cytomegalovirus Antibody ScreenLJO · Traditional | Immucor, Inc. | 03/20/1991SE |
| K852494 | Cmv-IhaLJO · Traditional | Hillcrest Biologicals | 09/16/1985SE |
| K841520 | CMV Latex Agglutination Test KitLJO · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 09/07/1984SE |
| K822965 | Cetus CMV IhaLJO · Traditional | Cetus Corp. | 02/15/1983SE |