FDA product code MCD: Antigen, Ebv, Capsid
MCD is the FDA product code for antigen, ebv, capsid. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel. FDA has cleared 8 510(k) submissions under MCD, from 5 different applicants. The average 510(k) review took 150 days (median 103).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Ebv, Capsid |
| Device class | Class I |
| Regulation | 21 CFR 866.3235 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every MCD clearance
Top MCD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ortho Diagnostic Systems, Inc. | 3 | 1992-06-22 |
| Zeus Scientific, Inc. | 2 | 1999-01-11 |
| Virion (U.S.), Inc. | 1 | 1994-06-13 |
| Fuller Laboratories, Inc. | 1 | 1993-10-12 |
| Gull Laboratories, Inc. | 1 | 1991-04-12 |
Most recent MCD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K984126 | Zeus Scientific, Inc. | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR | 1999-01-11 | 54 |
| K933251 | Virion (U.S.), Inc. | EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST | 1994-06-13 | 346 |
| K925689 | Fuller Laboratories, Inc. | MERIDIAN EBV-IGG TEST KIT | 1993-10-12 | 334 |
| K924091 | Zeus Scientific, Inc. | EBV-VCA IGG ELISA TEST SYSTEM | 1993-01-11 | 151 |
| K920412 | Ortho Diagnostic Systems, Inc. | MODIFIED ORTHO EBV VCA-IGG ELISA | 1992-06-22 | 143 |
Recalls for MCD devices
openFDA lists no recalls for product code MCD.
Frequently asked questions
What is FDA product code MCD?
MCD is the FDA product code for antigen, ebv, capsid. It is a Class I device, regulated under 21 CFR 866.3235 and reviewed by the Microbiology panel.
What device class is MCD?
Class I, regulation 21 CFR 866.3235. Typical premarket route: 510(k).
How long does a 510(k) take for product code MCD?
Across 8 cleared submissions the average was 150 days from receipt to decision (median 103).
Which companies have the most MCD clearances?
Ortho Diagnostic Systems, Inc. (3); Zeus Scientific, Inc. (2); Virion (U.S.), Inc. (1); Fuller Laboratories, Inc. (1); Gull Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MCD
- Run a recall and safety report across every MCD manufacturer
- Watch product code MCD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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