Antigen, Ebv, Capsid
The Epstein-Barr virus (EBV) viral capsid antigen reagent is a microbiology in vitro diagnostic device used to detect antibodies to EBV capsid antigen in patient serum, supporting the diagnosis of infectious mononucleosis and EBV-related conditions. It is classified as FDA Class I under 21 CFR 866.3235 within the Microbiology specialty, subject only to general controls. The product code is MCD and the device is not GMP-exempt. It is not implanted and does not sustain life.
Research product code MCD in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- MCD
- Device Class
- FDA class 1
- Regulation Number
- 866.3235
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K984126 | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | Jan 11, 1999 | Substantially Equivalent | Zeus Scientific, Inc. |
| K933251 | EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST | Jun 13, 1994 | Substantially Equivalent | Virion (U.S.), Inc. |
| K925689 | MERIDIAN EBV-IGG TEST KIT | Oct 12, 1993 | Substantially Equivalent | Fuller Laboratories, Inc. |
| K924091 | EBV-VCA IGG ELISA TEST SYSTEM | Jan 11, 1993 | Substantially Equivalent | Zeus Scientific, Inc. |
| K920412 | MODIFIED ORTHO EBV VCA-IGG ELISA | Jun 22, 1992 | Substantially Equivalent | Ortho Diagnostic Systems, Inc. |
| K911571 | EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST | Jun 10, 1991 | Substantially Equivalent | Ortho Diagnostic Systems, Inc. |
| K911570 | EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST | Jun 10, 1991 | Substantially Equivalent | Ortho Diagnostic Systems, Inc. |
| K910872 | EBV IGG ELISA TEST | Apr 12, 1991 | Substantially Equivalent | Gull Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.