LJO · Antigen, Iha, Cytomegalovirus
Microbiology · 21 CFR 866.3175 · Class 2
Overview
| Product Code | LJO |
|---|---|
| Device Name | Antigen, Iha, Cytomegalovirus |
| Regulation | 21 CFR 866.3175 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
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 (12 of 12)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K203612 | Capture-CMV | Immucor, Inc. | Mar 22, 2021 | SESE |
| K183571 | Capture-CMV | Immucor, Inc. | Feb 4, 2019 | SESE |
| K001767 | DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM | Diamedix Corp. | Aug 7, 2000 | SESE |
| K974901 | HYBRID CAPTURE SYSTEM CMV DNA ASSAY | Digene Corp. | Sep 29, 1998 | SESE |
| K974456 | CMVGEN | Instrumentation Laboratory CO | May 1, 1998 | SESE |
| K951851 | ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY | E.I. Dupont DE Nemours & Co., Inc. | Jul 24, 1996 | SESE |
| K955799 | COPALIS CMV TOTAL ANTIBODY ASSAY | Sienna Biotech, Inc. | Jul 10, 1996 | SESE |
| K920222 | HEALTHTEST ASSAY FOR ANTIBODY TO CYTOMEGALOVIRUS | Akers Research Corp. | Jul 27, 1992 | SESE |
| K910003 | CYTOMEGALOVIRUS ANTIBODY SCREEN | Immucor, Inc. | Mar 20, 1991 | SESE |
| K852494 | CMV-IHA | Hillcrest Biologicals | Sep 16, 1985 | SESE |
| K841520 | CMV LATEX AGGLUTINATION TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Sep 7, 1984 | SESE |
| K822965 | CETUS CMV IHA | Cetus Corp. | Feb 15, 1983 | SESE |
Top Applicants
- Immucor, Inc. — 3 clearances
- Akers Research Corp. — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Cetus Corp. — 1 clearance
- Diamedix Corp. — 1 clearance
