The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Epstein-barr Virus Vca-igg Antibody Elisa Test.
| Device ID | K911571 |
| 510k Number | K911571 |
| Device Name: | EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST |
| Classification | Antigen, Ebv, Capsid |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Contact | Kim W Gray |
| Correspondent | Kim W Gray ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Product Code | MCD |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-08 |
| Decision Date | 1991-06-10 |