MCD
8 FDA 510(k) clearances · Product code
143 daysmedian time to decision
346 days90th percentile
8clearances measured
FDA profile
- Official device name
- Antigen, Ebv, Capsid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR (K984126) | Zeus Scientific, Inc. | 1999-01-11 |
| EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST (K933251) | Virion (U.S.), Inc. | 1994-06-13 |
| MERIDIAN EBV-IGG TEST KIT (K925689) | Fuller Laboratories, Inc. | 1993-10-12 |
| EBV-VCA IGG ELISA TEST SYSTEM (K924091) | Zeus Scientific, Inc. | 1993-01-11 |
| MODIFIED ORTHO EBV VCA-IGG ELISA (K920412) | Ortho Diagnostic Systems, Inc. | 1992-06-22 |
| EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST (K911570) | Ortho Diagnostic Systems, Inc. | 1991-06-10 |
| EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST (K911571) | Ortho Diagnostic Systems, Inc. | 1991-06-10 |
| EBV IGG ELISA TEST (K910872) | Gull Laboratories, Inc. | 1991-04-12 |
Track MCD automatically
Every clearance here is in the API, with alerts when new ones post.