GNP · Class I · 21 CFR 866.3235

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

Leading manufacturers include Amico Lab, Inc., Diagnostic Technology, Inc. and Immuno Concepts, 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 Jan 24, 1989
EBV-VCA ANTIBODY (IGG)
K884591
Hillcrest Biologicals
Microbiology · 82d
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 Jun 25, 1987
EBV-CHECK(TM) TEST KIT (IGG)
K871373
Diagnostic Technology, Inc.
Microbiology · 79d
Cleared Nov 28, 1986
EBV/VCA-CHECK(TM) ANTIGEN SLIDES
K863408
Diagnostic Technology, Inc.
Microbiology · 86d
Cleared Dec 12, 1985
ANTI-EPSTEIN-BARR VIRUS KIT
K842662
Amico Lab, Inc.
Immunology · 520d
Cleared Dec 06, 1985
AMIZYME-EBV TEST KIT
K842530
Amico Lab, Inc.
Immunology · 526d
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