MCD — Antigen, Ebv, Capsid Class I
FDA product code MCD covers "Antigen, Ebv, Capsid", a Class I medical device regulated under 21 CFR 866.3235. Submissions are reviewed by the Microbiology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MCD
- Device Class
- Class I
- Regulation Number
- 866.3235
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K984126 | zeus scientific | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYM | January 11, 1999 |
| K933251 | virion (u.s.) | EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST | June 13, 1994 |
| K925689 | fuller laboratories | MERIDIAN EBV-IGG TEST KIT | October 12, 1993 |
| K924091 | zeus scientific | EBV-VCA IGG ELISA TEST SYSTEM | January 11, 1993 |
| K920412 | ortho diagnostic systems | MODIFIED ORTHO EBV VCA-IGG ELISA | June 22, 1992 |
| K911570 | ortho diagnostic systems | EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST | June 10, 1991 |
| K911571 | ortho diagnostic systems | EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST | June 10, 1991 |
| K910872 | gull laboratories | EBV IGG ELISA TEST | April 12, 1991 |