GQI · Antiserum, Cf, Cytomegalovirus
Microbiology · 21 CFR 866.3175 · Class 2
Overview
| Product Code | GQI |
|---|---|
| Device Name | Antiserum, Cf, 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 (18 of 18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K952254 | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | Pyramid Biological Corp. | Nov 16, 1995 | SESE |
| K951800 | CMV IGG HUMAN SERUM CONTROLS | Pyramid Biological Corp. | Nov 16, 1995 | SESE |
| K942171 | CMV EARLY ANTIGEN TEST | Neogenex | Jun 30, 1994 | SESE |
| K883102 | VIRGO (R) CMV-IGG ELISA | Electro-Nucleonics, Inc. | Feb 8, 1989 | SESE |
| K875159 | DETECTADOT SYSTEM 2000 CMV IGG TEST | Gull Laboratories, Inc. | May 6, 1988 | SESE |
| K863488 | ENZYGNOST ANTI-CMV IGG TEST | Behring Diagnostics, Inc. | Jul 20, 1987 | SESE |
| K864420 | CMV MICROASSAY | Diamedix Corp. | Feb 2, 1987 | SESE |
| K861123 | THE GOLDEN QUAD TEST (CMV) | Microbiological Research Corp. | Feb 2, 1987 | SESE |
| K862705 | CYTOMEGALOVIRUS IGG EIA TEST KIT | Labsystems, Inc. | Oct 1, 1986 | SESE |
| K853989 | COR DOT CMV | Cordis Corp. | Jun 13, 1986 | SESE |
| K860493 | CYTOTECH CMV IGG EIA | Cytotech, Inc. | May 20, 1986 | SESE |
| K854666 | CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530 | Clinical Sciences, Inc. | Feb 5, 1986 | SESE |
| K843189 | CYTOMEGALOVIRUS IGG EIA TEST KIT | Labsystems, Inc. | Jan 8, 1986 | SESE |
| K842661 | ANTI-CYTOMEGALOVIRUS KIT | Amico Lab, Inc. | Dec 6, 1985 | SESE |
| K842529 | AMIZYME-CMV KIT | Amico Lab, Inc. | Dec 6, 1985 | SESE |
| K853137 | CMV TEST | Gull Laboratories, Inc. | Nov 14, 1985 | SESE |
| K852929 | CMV-COMPLEMENT FIXATION ANTIGEN AND NEGATIVE CONTR | Microbix Biosystems, Inc. | Nov 12, 1985 | SESE |
| K853277 | CMV CF ANTIGEN | Hillcrest Biologicals | Nov 7, 1985 | SESE |
Top Applicants
- Amico Lab, Inc. — 2 clearances
- Gull Laboratories, Inc. — 2 clearances
- Labsystems, Inc. — 2 clearances
- Pyramid Biological Corp. — 2 clearances
- Behring Diagnostics, Inc. — 1 clearance
