LFZ · Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus
Microbiology · 21 CFR 866.3175 · Class 2
Overview
| Product Code | LFZ |
|---|---|
| Device Name | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus |
| Regulation | 21 CFR 866.3175 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 58)
Showing 20 most recent of 58 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220949 | Architect CMV IgG | Abbott Laboratories | Oct 27, 2022 | SESE |
| K220911 | Elecsys CMV IgG | Roche Diagnostics | Oct 12, 2022 | SESE |
| K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control | Siemens Healthcare Diagnostics, Inc. | Jul 30, 2018 | SESE |
| K163569 | Elecsys CMV IgM | Roche Diagnostics | Mar 17, 2017 | SESE |
| K162969 | LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set | DiaSorin, Inc. | Jan 6, 2017 | SESE |
| K142133 | ELECYS CMV IGM IMMUNOASSAY; ELECYS PRECICONTROL CMV IGM | Roche Diagnostics | Oct 24, 2014 | SESE |
| K131605 | ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY | Roche Diagnostics | Feb 28, 2014 | SESE |
| K040290 | DIASORIN LIAISON CMV IGM/IGG | Diasorin S.P.A | Jun 1, 2005 | SESE |
| K993952 | IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 | Diagnostic Products Corp. | Dec 16, 1999 | SESE |
| K982485 | SERAQUEST CMV IGM | Quest Intl., Inc. | Jan 13, 1999 | SESE |
| K984139 | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | Jan 11, 1999 | SESE |
| K983803 | THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE | Zeus Scientific, Inc. | Dec 14, 1998 | SESE |
| K982027 | MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY | DiaSorin, Inc. | Nov 25, 1998 | SESE |
| K981163 | DIAMEDIX IS-CMV IGG TEST SYSTEM | Diamedix Corp. | Sep 21, 1998 | SESE |
| K971335 | QUANTA LITE CMV IGG ELISA | Inova Diagnostics, Inc. | Dec 1, 1997 | SESE |
| K954301 | ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) | Abbott Laboratories | Mar 24, 1997 | SESE |
| K944438 | HEMAGEN CMV IGG KIT | Hemagen Diagnostics, Inc. | Feb 20, 1997 | SESE |
| K960434 | INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 | Incstar Corp. | Oct 17, 1996 | SESE |
| K963084 | OPUS CMV TEST SYSTEM-MODIFICATION | Behring Diagnostics, Inc. | Oct 9, 1996 | SESE |
| K953943 | AXSYM CMV IGG ANTIBODY ASSAY | Abbott Laboratories | Sep 20, 1996 | SESE |
Top Applicants
- Abbott Laboratories — 6 clearances
- Zeus Scientific, Inc. — 5 clearances
- Behring Diagnostics, Inc. — 5 clearances
- Roche Diagnostics — 4 clearances
- Gull Laboratories, Inc. — 4 clearances
