LKQ · Antibody Igm,If, Cytomegalovirus Virus
Microbiology · 21 CFR 866.3175 · Class 2
Overview
| Product Code | LKQ |
|---|---|
| Device Name | Antibody Igm,If, Cytomegalovirus Virus |
| 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 |
|---|---|---|---|---|
| K100433 | IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2, | Siemens Healthcare Diagnostics | May 13, 2010 | SESE |
| K972884 | ACCURUN 146 CMV IGM POSITIVE CONTROL | Boston Biomedica, Inc. | Aug 22, 1997 | SESE |
| K933549 | VIDAS CMV IGM ASSAY | Biomerieux Vitek, Inc. | Aug 2, 1994 | SESE |
| K922580 | BARTELS CYTOMEGALOVIRUS IGM EIA | Baxter Diagnostics, Inc. | Apr 8, 1993 | SESE |
| K914789 | ELISA CMV IGM | Sclavo, Inc. | Mar 4, 1992 | SESE |
| K913080 | OPUS(R) ANTI CMV-M | Pb Diagnostics, Inc. | Oct 28, 1991 | SESE |
| K900743 | CMV-IGM IFA TEST SYSTEM | Zeus Scientific, Inc. | Apr 26, 1990 | SESE |
| K893465 | CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | Immuno Concepts, Inc. | Jul 25, 1989 | SESE |
| K893466 | CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST) | Immuno Concepts, Inc. | Jul 14, 1989 | SESE |
| K872881 | ABBOTT CMV-M EIA KIT | Abbott Laboratories | May 13, 1988 | SESE |
| K872942 | IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530 | Clinical Sciences, Inc. | Jan 11, 1988 | SESE |
| K871832 | CMV IGM MICROASSAY | Diamedix Corp. | Aug 7, 1987 | SESE |
| K863798 | FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES | Whittaker Bioproducts, Inc. | Apr 14, 1987 | SESE |
| K861363 | ENZYGNOST ANTI-CMV IGM TEST | Behring Diagnostics, Inc. | Jul 21, 1986 | SESE |
| K860450 | THE CMV-IGM TEST | Microbiological Research Corp. | May 13, 1986 | SESE |
| K853889 | CORDIA CMV-M | Cordis Corp. | Apr 21, 1986 | SESE |
| K854839 | CYTOMEGELISA M TEST KIT | Whittaker Bioproducts, Inc. | Feb 4, 1986 | SESE |
| K831711 | CMV IGM TEST | Gull Laboratories, Inc. | Oct 27, 1983 | SESE |
Top Applicants
- Immuno Concepts, Inc. — 2 clearances
- Whittaker Bioproducts, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
- Baxter Diagnostics, Inc. — 1 clearance
- Behring Diagnostics, Inc. — 1 clearance
