The following data is part of a premarket notification filed by Virion (u.s.), Inc. with the FDA for Epstein-barr Virus Combi Test, Ebv Combi Test.
| Device ID | K933251 |
| 510k Number | K933251 |
| Device Name: | EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST |
| Classification | Antigen, Ebv, Capsid |
| Applicant | VIRION (U.S.), INC. 4 UPPERFIELD RD. Morristown, NJ 07960 |
| Contact | William J Hausler, Jr., Ph.d |
| Correspondent | William J Hausler, Jr., Ph.d VIRION (U.S.), INC. 4 UPPERFIELD RD. Morristown, NJ 07960 |
| Product Code | MCD |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-02 |
| Decision Date | 1994-06-13 |