LJO
12 FDA 510(k) clearances · Product code
148 daysmedian time to decision
272 days90th percentile
12clearances measured
FDA profile
- Official device name
- Antigen, Iha, Cytomegalovirus
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3175
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Capture-CMV (K203612) | Immucor, Inc. | 2021-03-22 |
| Capture-CMV (K183571) | Immucor, Inc. | 2019-02-04 |
| DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM (K001767) | Diamedix Corp. | 2000-08-07 |
| HYBRID CAPTURE SYSTEM CMV DNA ASSAY (K974901) | Digene Corp. | 1998-09-29 |
| CMVGEN (K974456) | Instrumentation Laboratory CO | 1998-05-01 |
| ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY (K951851) | E.I. Dupont DE Nemours & Co., Inc. | 1996-07-24 |
| COPALIS CMV TOTAL ANTIBODY ASSAY (K955799) | Sienna Biotech, Inc. | 1996-07-10 |
| HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS (K920222) | Akers Research Corp. | 1992-07-27 |
| CYTOMEGALOVIRUS ANTIBODY SCREEN (K910003) | Immucor, Inc. | 1991-03-20 |
| CMV-IHA (K852494) | Hillcrest Biologicals | 1985-09-16 |
| CMV LATEX AGGLUTINATION TEST KIT (K841520) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-09-07 |
| CETUS CMV IHA (K822965) | Cetus Corp. | 1983-02-15 |
Track LJO automatically
Every clearance here is in the API, with alerts when new ones post.