Product code LFZ
- Device name
- Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- Medical specialty
- Microbiology
- Device class
- 2
- Regulation number
- 866.3175
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K220949 | Architect CMV IgG | Abbott Laboratories | 2022-10-27 |
| K220911 | Elecsys CMV IgG | Roche Diagnostics | 2022-10-12 |
| K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control | Siemens Healthcare Diagnostics, Inc. | 2018-07-30 |
| K163569 | Elecsys CMV IgM | Roche Diagnostics | 2017-03-17 |
| K162969 | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set | DiaSorin, Inc. | 2017-01-06 |
| K142133 | ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM | Roche Diagnostics | 2014-10-24 |
| K131605 | ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY | Roche Diagnostics | 2014-02-28 |
| K040290 | DIASORIN LIAISON CMV IGM/IGG | Diasorin S.P.A | 2005-06-01 |
| K993952 | IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 | Diagnostic Products Corp. | 1999-12-16 |
| K982485 | SERAQUEST CMV IGM | Quest Intl., Inc. | 1999-01-13 |
| K984139 | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | 1999-01-11 |
| K983803 | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | 1998-12-14 |
| K982027 | MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY | DiaSorin, Inc. | 1998-11-25 |
| K981163 | DIAMEDIX IS-CMV IGG TEST SYSTEM | Diamedix Corp. | 1998-09-21 |
| K971335 | QUANTA LITE CMV IGG ELISA | Inova Diagnostics, Inc. | 1997-12-01 |
| K954301 | ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) | Abbott Laboratories | 1997-03-24 |
| K944438 | HEMAGEN CMV IGG KIT | Hemagen Diagnostics, Inc. | 1997-02-20 |
| K960434 | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 | Incstar Corp. | 1996-10-17 |
| K963084 | OPUS CMV TEST SYSTEM-MODIFICATION | Behring Diagnostics, Inc. | 1996-10-09 |
| K953943 | AXSYM CMV IGG ANTIBODY ASSAY | Abbott Laboratories | 1996-09-20 |
| K955361 | INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY | Incstar Corp. | 1996-07-22 |
| K955360 | INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY | Incstar Corp. | 1996-07-22 |
| K950672 | IMMULITE CMV IGG | Diagnostic Products Corp. | 1996-06-17 |
| K954191 | SERAQUEST CMV IGG | Quest Intl., Inc. | 1996-02-23 |
| K933389 | OPUS CMV-G | Pb Diagnostic Systems, Inc. | 1994-06-28 |
| K922582 | BARTELS CYTOMEGALOVIRUS IGG EIA | Baxter Diagnostics, Inc. | 1993-04-08 |
| K924096 | CMV ELISA TEST SYSTEM | Zeus Scientific, Inc. | 1993-04-02 |
| K920661 | VIDAS CMV IGG ASSAY | Vitek Systems, Inc. | 1993-02-12 |
| K921011 | PHARMACIA CMV IGM ELISA | Pharmacia Diagnostics, Inc. | 1992-07-27 |
| K915479 | CAPTIA CMV-TA | Mercia Diagnostics , Ltd. | 1992-05-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00816870024295 | CMV IgM AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024288 | CMV IgM AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024257 | CMV IgG AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870024240 | CMV IgG AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 04048474027976 | CMV IgG ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-29 |
| 00840239027979 | CMV IgG ELISA | DRG International Inc | 2023-08-24 |
| 00380740181093 | Alinity | Abbott Ireland Diagnostics | 2023-07-14 |
| 00380740181109 | Alinity | Abbott Ireland Diagnostics | 2023-07-14 |
| 07613336193082 | Elecsys CMV IgG | Roche Diagnostics GmbH | 2022-12-07 |
| 07613336198469 | Elecsys CMV IgG | Roche Diagnostics GmbH | 2022-12-06 |
| 00894175000558 | AccuDiag™ | Diagnostic Automation, Inc. | 2021-11-29 |
| 00894175000053 | AccuDiag ™ | Diagnostic Automation, Inc. | 2021-08-10 |
| B3507203200 | Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit | Gold Standard Diagnostics Corporation | 2020-06-03 |
| 05391516746885 | Trinity Biotech | CLARK LABORATORIES, INC. | 2019-12-27 |
| 00630414588872 | ADVIA Centaur CMV IgG | Siemens Healthcare Diagnostics Inc. | 2019-02-10 |
| 03610521167488 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-08-05 |
| 03610520992715 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-08-05 |
| 03610520150269 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2017-08-05 |
| 04015630940172 | Elecsys CMV IgG | Roche Diagnostics GmbH | 2017-04-21 |
| 04015630940189 | Elecsys CMV IgM | Roche Diagnostics GmbH | 2017-04-17 |
| 08056771101943 | LIAISON® CMV IgM | DIASORIN SPA | 2016-09-24 |
| 05391516743426 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-21 |
| 05391516743419 | Trinity Biotech | CLARK LABORATORIES, INC. | 2016-09-21 |
| 04015630938926 | Elecsys CMV IgM Immunoassay | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630937172 | Elecsys CMV IgG Assay | Roche Diagnostics GmbH | 2016-09-20 |
| 00847865012577 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865011006 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865003179 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 00847865001175 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. | 2016-09-12 |
| 03573026156831 | VIDAS® CMV IgG | BIOMERIEUX SA | 2016-08-31 |