LFZ — Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus Class II
FDA product code LFZ covers "Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus", a Class II medical device regulated under 21 CFR 866.3175. Submissions are reviewed by the Microbiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LFZ
- 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 |
|---|---|---|---|
| K220949 | abbott laboratories | Architect CMV IgG | October 27, 2022 |
| K220911 | roche diagnostics | Elecsys CMV IgG | October 12, 2022 |
| K181213 | siemens healthcare diagnostics | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control | July 30, 2018 |
| K163569 | roche diagnostics | Elecsys CMV IgM | March 17, 2017 |
| K162969 | diasorin | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set | January 6, 2017 |
| K142133 | roche diagnostics | ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM | October 24, 2014 |
| K131605 | roche diagnostics | ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY | February 28, 2014 |
| K040290 | diasorin | DIASORIN LIAISON CMV IGM/IGG | June 1, 2005 |
| K993952 | diagnostic products | IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 | December 16, 1999 |
| K982485 | quest intl | SERAQUEST CMV IGM | January 13, 1999 |
| K984139 | zeus scientific | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LI | January 11, 1999 |
| K983803 | zeus scientific | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LI | December 14, 1998 |
| K982027 | diasorin | MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY | November 25, 1998 |
| K981163 | diamedix | DIAMEDIX IS-CMV IGG TEST SYSTEM | September 21, 1998 |
| K971335 | inova diagnostics | QUANTA LITE CMV IGG ELISA | December 1, 1997 |
| K954301 | abbott laboratories | ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) | March 24, 1997 |
| K944438 | hemagen diagnostics | HEMAGEN CMV IGG KIT | February 20, 1997 |
| K960434 | incstar | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 | October 17, 1996 |
| K963084 | behring diagnostics | OPUS CMV TEST SYSTEM-MODIFICATION | October 9, 1996 |
| K953943 | abbott laboratories | AXSYM CMV IGG ANTIBODY ASSAY | September 20, 1996 |