GNP · Class I · 21 CFR 866.3235

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

Leading manufacturers include Pan Bio Pty. , Ltd., Amico Lab, Inc. and Diagnostic Technology, 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 Jun 13, 2002
EBV-VCA IGG ELISA TEST, MODEL EBG-100
K020706
Pan Bio Pty. , Ltd.
Microbiology · 101d
Cleared Jun 13, 2002
EBV-EBNA IGG ELISA KIT, MODEL EBG-100
K020707
Pan Bio Pty. , Ltd.
Microbiology · 101d
Cleared Jun 13, 2002
EBV V VCA IGM ELISA KIT MODEL# EBM-200
K020717
Pan Bio Pty. , Ltd.
Microbiology · 100d
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 Sep 12, 1990
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM
K901156
Granbio, Inc.
Microbiology · 183d
Cleared Apr 28, 1989
SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI
K883670
Electro-Nucleonics, Inc.
Microbiology · 253d
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 Feb 02, 1987
THE GOLDEN QUAD TEST (EBV)
K861121
Microbiological Research Corp.
Microbiology · 314d
Cleared Feb 02, 1987
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA
K864347
Granbio, Inc.
Microbiology · 90d
Cleared Nov 28, 1986
EBV/VCA-CHECK(TM) ANTIGEN SLIDES
K863408
Diagnostic Technology, Inc.
Microbiology · 86d
Cleared Apr 24, 1986
EBV(EPSTEIN-BARR VIRUS) TEST KIT
K854207
Immuno-Diagnostic Products, Inc.
Microbiology · 190d
Cleared Feb 05, 1986
INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT
K853484
Biotech Research Laboratories, Inc.
Microbiology · 169d
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