LJO — Antigen, Iha, Cytomegalovirus Class II
FDA Device Classification
Classification Details
- Product Code
- LJO
- Device Class
- Class II
- Regulation Number
- 866.3175
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K203612 | immucor | Capture-CMV | March 22, 2021 |
| K183571 | immucor | Capture-CMV | February 4, 2019 |
| K001767 | diamedix | DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM | August 7, 2000 |
| K974901 | digene | HYBRID CAPTURE SYSTEM CMV DNA ASSAY | September 29, 1998 |
| K974456 | instrumentation laboratory | CMVGEN | May 1, 1998 |
| K951851 | e.i. dupont de nemours and co | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY | July 24, 1996 |
| K955799 | sienna biotech | COPALIS CMV TOTAL ANTIBODY ASSAY | July 10, 1996 |
| K920222 | akers research | HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS | July 27, 1992 |
| K910003 | immucor | CYTOMEGALOVIRUS ANTIBODY SCREEN | March 20, 1991 |
| K852494 | hillcrest biologicals | CMV-IHA | September 16, 1985 |
| K841520 | bd becton dickinson vacutainer systems preanalytic | CMV LATEX AGGLUTINATION TEST KIT | September 7, 1984 |
| K822965 | cetus | CETUS CMV IHA | February 15, 1983 |