FDA 510(k) Applications for Medical Device Product Code "LFZ"
(Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K954301 | ABBOTT LABORATORIES | ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) | 03/24/1997 |
| K220949 | Abbott Laboratories | Architect CMV IgG | 10/27/2022 |
| K953943 | ABBOTT LABORATORIES | AXSYM CMV IGG ANTIBODY ASSAY | 09/20/1996 |
| K963084 | BEHRING DIAGNOSTICS, INC. | OPUS CMV TEST SYSTEM-MODIFICATION | 10/09/1996 |
| K993952 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 | 12/16/1999 |
| K950672 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE CMV IGG | 06/17/1996 |
| K981163 | DIAMEDIX CORP. | DIAMEDIX IS-CMV IGG TEST SYSTEM | 09/21/1998 |
| K162969 | DiaSorin Inc. | LIAISON« CMV IgG and LIAISON« CMV IgG Serum Control Set | 01/06/2017 |
| K040290 | DIASORIN S.P.A. | DIASORIN LIAISON CMV IGM/IGG | 06/01/2005 |
| K982027 | DIASORIN, INC. | MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY | 11/25/1998 |
| K944438 | HEMAGEN DIAGNOSTICS, INC. | HEMAGEN CMV IGG KIT | 02/20/1997 |
| K955361 | INCSTAR CORP. | INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY | 07/22/1996 |
| K955360 | INCSTAR CORP. | INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY | 07/22/1996 |
| K960434 | INCSTAR CORP. | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 | 10/17/1996 |
| K971335 | INOVA DIAGNOSTICS, INC. | QUANTA LITE CMV IGG ELISA | 12/01/1997 |
| K954191 | QUEST INTL., INC. | SERAQUEST CMV IGG | 02/23/1996 |
| K982485 | QUEST INTL., INC. | SERAQUEST CMV IGM | 01/13/1999 |
| K220911 | Roche Diagnostics | Elecsys CMV IgG | 10/12/2022 |
| K163569 | Roche Diagnostics | Elecsys CMV IgM | 03/17/2017 |
| K131605 | Roche Diagnostics | ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY | 02/28/2014 |
| K142133 | Roche Diagnostics | ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM | 10/24/2014 |
| K181213 | Siemens Healthcare Diagnostics, Inc. | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control | 07/30/2018 |
| K984139 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | 01/11/1999 |
| K983803 | ZEUS SCIENTIFIC, INC. | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | 12/14/1998 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
