GNP · Class I · 21 CFR 866.3235

FDA Product Code GNP: Antiserum, Cf, Epstein-barr Virus

Leading manufacturers include Immuno Concepts, Inc., Diamedix Corp. and Gull Laboratories, Inc..

20
Total
20
Cleared
188d
Avg days
1977
Since

FDA 510(k) Cleared Antiserum, Cf, Epstein-barr Virus Devices (Product Code GNP)

20 devices
1–20 of 20
Cleared Feb 16, 1999
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM
K981829
Diamedix Corp.
Microbiology · 270d
Cleared Feb 16, 1999
IS EBV-EA-D IGG ELISA TEST SYSTEM
K981831
Diamedix Corp.
Microbiology · 270d
Cleared Aug 30, 1988
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)
K880883
Immuno Concepts, Inc.
Microbiology · 181d
Cleared Aug 30, 1988
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)
K880885
Immuno Concepts, Inc.
Microbiology · 181d
Cleared May 05, 1981
ENI ANTIBODY TO EPSTEIN-BARR VIRUS
K810860
Electro-Nucleonics Laboratories, Inc.
Microbiology · 36d
Cleared Jul 14, 1977
EBV TEST
K771062
Gull Laboratories, Inc.
Microbiology · 31d

About Product Code GNP - Regulatory Context