Product code MCD— Microbiology
EBV IGG ELISA TEST
- Classification name
- Antigen, Ebv, Capsid
- Device class
- Class 1
- Regulation
- 21 CFR 866.3235
- Advisory panel
- Microbiology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code MCD
FDA has cleared devices under product code MCD between 1991 and 1999, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1999
- 1994
- 1993
- 1992
- 1991
Top applicants under product code MCD
Recent clearances under product code MCD
- K984126 — THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
- K933251 — EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST
- K925689 — MERIDIAN EBV-IGG TEST KIT
- K924091 — EBV-VCA IGG ELISA TEST SYSTEM
- K920412 — MODIFIED ORTHO EBV VCA-IGG ELISA
- K911570 — EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST
- K911571 — EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST
- K910872 — EBV IGG ELISA TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.