GQH · Antigen, Cf (Including Cf Control), Cytomegalovirus
Microbiology · 21 CFR 866.3175 · Class 2
Overview
| Product Code | GQH |
|---|---|
| Device Name | Antigen, Cf (Including Cf Control), 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 (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K982311 | BARTELS CINAKIT CMV ANTIGENEMIA | Intracel Corp. | Dec 14, 1998 | SESE |
| K964875 | CMV ANTIGEN CONTROL SLIDES | Viral Antigens, Inc. | Mar 18, 1997 | SESE |
| K935809 | CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | May 5, 1994 | SESE |
| K882835 | INDIRECT FLUORESCENT ASSAY FOR (HCMV) | Stellar Bio Systems, Inc. | Dec 5, 1988 | SESE |
| K882024 | FITC MURINE MONOCLONAL ANTI-CMV IGG | Whittaker Bioproducts, Inc. | Aug 3, 1988 | SESE |
| K881932 | ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENT | Ortho Diagnostic Systems, Inc. | Aug 1, 1988 | SESE |
| K880679 | BION CMV-G TEST SYSTEM | Bion Ent., Ltd. | Jun 3, 1988 | SESE |
| K880290 | MICROTRAK CMV CULTURE CONFIRMATION TEST | Syva Co. | Apr 19, 1988 | SESE |
| K872576 | COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION | Enzo Biochem, Inc. | Dec 4, 1987 | SESE |
| K873114 | CYTOMEGALOVIRUS CONTROL SLIDES | Medical Diagnostic Technologies, Inc. | Sep 25, 1987 | SESE |
| K864565 | MONABRITE CYTOMEGALOVIRUS (CMV) IFA KIT | Serono Diagnostics, Inc. | Feb 19, 1987 | SESE |
| K843657 | CYTOMEGALOVIRUS | Institute Virion , Ltd. | Sep 26, 1985 | SESE |
| K833089 | CYTOMEGALOVIRUS ANTIBODY FLUORO-KIT II | Clinical Sciences, Inc. | May 2, 1984 | SESE |
| K811671 | CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM | Zeus Scientific, Inc. | Sep 16, 1981 | SESE |
| K802930 | CYTOMEGALO VIRUS & CONTROLS | Orion Diagnostica, Inc. | Jan 9, 1981 | SESE |
| K801963 | CMV TEST KIT | Immuno-Diagnostic Products, Inc. | Oct 23, 1980 | SESE |
| K801722 | CMV BIO-BEAD TITRATION KIT | Litton Bionetics | Sep 16, 1980 | SESE |
| K791948 | FIAX TEST KIT FOR ANTI-CYTOMEGALORIRUS | Intl. Diagnostic Technology | Nov 16, 1979 | SESE |
| K791612 | CMV BIO-BEAD SCREEN KIT | Litton Bionetics | Nov 13, 1979 | SESE |
Top Applicants
- Litton Bionetics — 2 clearances
- Bion Ent., Ltd. — 1 clearance
- Clinical Sciences, Inc. — 1 clearance
- Enzo Biochem, Inc. — 1 clearance
- Immuno-Diagnostic Products, Inc. — 1 clearance
