LIN · Antisera, Conjugated Fluorescent, Cytomegalovirus
Microbiology · 21 CFR 866.3175 · Class 2
Overview
| Product Code | LIN |
|---|---|
| Device Name | Antisera, Conjugated Fluorescent, 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 (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K081164 | D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT | Diagnostic Hybrids, Inc. | Jun 13, 2008 | SESE |
| K983762 | NUCLISENS CMV PP67 | Organon Teknika Corp. | Sep 15, 1999 | SESE |
| K991650 | CMV BRITE TURBO KIT | Biotest Diagnostics Corp. | Jul 12, 1999 | SESE |
| K951821 | CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | Jun 7, 1996 | SESE |
| K951550 | CMV BRITE ANTIGENEMIA TEST KIT | Biotest Diagnostics Corp. | Jan 30, 1996 | SESE |
| K934798 | PATHODX CYTOMEGALOVIRUS | Diagnostic Products Corp. | Mar 25, 1994 | SESE |
| K921616 | CMV-VUE(TM) CMV ANTIGEN DETECTION KIT | Incstar Corp. | Aug 11, 1992 | SN |
| K912592 | CMV-EA MAB TEST | Gull Laboratories, Inc. | Dec 4, 1991 | SESE |
| K905257 | OPUS CMV TEST SYSTEM | Pb Diagnostic Systems, Inc. | Apr 17, 1991 | SESE |
| K904036 | BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN | Baxter Healthcare Corp | Oct 16, 1990 | SESE |
| K894002 | CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY | Baxter Healthcare Corp | Aug 10, 1989 | SESE |
| K893468 | CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | Immuno Concepts, Inc. | Jul 14, 1989 | SESE |
| K893467 | CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) | Immuno Concepts, Inc. | Jul 14, 1989 | SESE |
| K860279 | CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT | Bartels Immunodiagnostic Supplies, Inc. | May 13, 1986 | SESE |
| K843138 | CMV TEST | Microbiological Research Corp. | Jan 29, 1985 | SESE |
| K822606 | CYTOMEGALOVIRUS ANTOBODY IGG | Immulok, Inc. | Nov 1, 1982 | SESE |
| K820895 | CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI | Bartels Immunodiagnostic Supplies, Inc. | May 3, 1982 | SESE |
Top Applicants
- Bartels Immunodiagnostic Supplies, Inc. — 2 clearances
- Baxter Healthcare Corp — 2 clearances
- Biotest Diagnostics Corp. — 2 clearances
- Immuno Concepts, Inc. — 2 clearances
- Diagnostic Hybrids, Inc. — 1 clearance
