LJO — Antigen, Iha, Cytomegalovirus Class II
FDA product code LJO covers "Antigen, Iha, Cytomegalovirus", a Class II medical device regulated under 21 CFR 866.3175. Submissions are reviewed by the Microbiology panel. At least 12 recent 510(k) clearances have been granted under this product code.
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 |