MCD · Antigen, Ebv, Capsid
Microbiology · 21 CFR 866.3235 · Class 1
Overview
| Product Code | MCD |
|---|---|
| Device Name | Antigen, Ebv, Capsid |
| Regulation | 21 CFR 866.3235 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
| 3rd-Party Reviewable | Yes |
Identification
Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).
Classification Rationale
Class I (general controls).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K984126 | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Zeus Scientific, Inc. | Jan 11, 1999 | SESE |
| K933251 | EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST | Virion (U.S.), Inc. | Jun 13, 1994 | SESE |
| K925689 | MERIDIAN EBV-IGG TEST KIT | Fuller Laboratories, Inc. | Oct 12, 1993 | SESE |
| K924091 | EBV-VCA IGG ELISA TEST SYSTEM | Zeus Scientific, Inc. | Jan 11, 1993 | SESE |
| K920412 | MODIFIED ORTHO EBV VCA-IGG ELISA | Ortho Diagnostic Systems, Inc. | Jun 22, 1992 | SESE |
| K911571 | EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | Jun 10, 1991 | SESE |
| K911570 | EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST | Ortho Diagnostic Systems, Inc. | Jun 10, 1991 | SESE |
| K910872 | EBV IGG ELISA TEST | Gull Laboratories, Inc. | Apr 12, 1991 | SESE |
Top Applicants
- Ortho Diagnostic Systems, Inc. — 3 clearances
- Zeus Scientific, Inc. — 2 clearances
- Fuller Laboratories, Inc. — 1 clearance
- Gull Laboratories, Inc. — 1 clearance
- Virion (U.S.), Inc. — 1 clearance
