Panels › Microbiology › Product code MCD · Class 1
Antigen, Ebv, Capsid
Regulation 866.3235
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MCD
| Company | 510(k)s | Recalls |
|---|---|---|
| Ortho Diagnostic Systems, Inc. | 3 | 0 |
| Zeus Scientific, Inc. | 2 | 0 |
| Fuller Laboratories, Inc. | 1 | 0 |
| Gull Laboratories, Inc. | 1 | 0 |
| Virion (U.S.), Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 11, 1999 | K984126 | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR Zeus Scientific, Inc. | MCD |
| Jun 13, 1994 | K933251 | EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST Virion (U.S.), Inc. | MCD |
| Oct 12, 1993 | K925689 | MERIDIAN EBV-IGG TEST KIT Fuller Laboratories, Inc. | MCD |
| Jan 11, 1993 | K924091 | EBV-VCA IGG ELISA TEST SYSTEM Zeus Scientific, Inc. | MCD |
| Jun 22, 1992 | K920412 | MODIFIED ORTHO EBV VCA-IGG ELISA Ortho Diagnostic Systems, Inc. | MCD |
| Jun 10, 1991 | K911571 | EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | MCD |
| Jun 10, 1991 | K911570 | EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST Ortho Diagnostic Systems, Inc. | MCD |
| Apr 12, 1991 | K910872 | EBV IGG ELISA TEST Gull Laboratories, Inc. | MCD |
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