MCD · Class I · 21 CFR 866.3235

FDA Product Code MCD: Antigen, Ebv, Capsid

Leading manufacturers include Ortho Diagnostic Systems, Inc., Zeus Scientific, Inc. and Gull Laboratories, Inc..

8
Total
8
Cleared
150d
Avg days
1991
Since

FDA 510(k) Cleared Antigen, Ebv, Capsid Devices (Product Code MCD)

8 devices
1–8 of 8
Cleared Jan 11, 1999
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K984126
Zeus Scientific, Inc.
Microbiology · 54d
Cleared Jan 11, 1993
EBV-VCA IGG ELISA TEST SYSTEM
K924091
Zeus Scientific, Inc.
Microbiology · 151d
Cleared Jun 22, 1992
MODIFIED ORTHO EBV VCA-IGG ELISA
K920412
Ortho Diagnostic Systems, Inc.
Microbiology · 143d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST
K911570
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Jun 10, 1991
EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST
K911571
Ortho Diagnostic Systems, Inc.
Microbiology · 63d
Cleared Apr 12, 1991
EBV IGG ELISA TEST
K910872
Gull Laboratories, Inc.
Microbiology · 42d

About Product Code MCD - Regulatory Context