Atlas FDA

GNP

20 FDA 510(k) clearances · Product code

181 daysmedian time to decision
520 days90th percentile
20clearances measured

FDA profile

Official device name
Antiserum, Cf, Epstein-Barr Virus
Device class
Class I (low risk)
Regulation
21 CFR 866.3235
Medical specialty
Microbiology
Flags
Third-party review eligible
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RecordFirmDate
EBV V VCA IGM ELISA KIT MODEL# EBM-200 (K020717)Pan Bio Pty. , Ltd.2002-06-13
EBV-VCA IGG ELISA TEST, MODEL EBG-100 (K020706)Pan Bio Pty. , Ltd.2002-06-13
EBV-EBNA IGG ELISA KIT, MODEL EBG-100 (K020707)Pan Bio Pty. , Ltd.2002-06-13
IS EBV-EA-D IGG ELISA TEST SYSTEM (K981831)Diamedix Corp.1999-02-16
IS EBV-EBNA-1 IGG ELISA TEST SYSTEM (K981829)Diamedix Corp.1999-02-16
EIA FOR IGG ANTIBODY TO EBV VCA IN HUMAN SERUM (K901156)Granbio, Inc.1990-09-12
SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI (K883670)Electro-Nucleonics, Inc.1989-04-28
EBV-VCA ANTIBODY (IGG) (K884591)Hillcrest Biologicals1989-01-24
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME) (K880885)Immuno Concepts, Inc.1988-08-30
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT) (K880883)Immuno Concepts, Inc.1988-08-30
EBV-CHECK(TM) TEST KIT (IGG) (K871373)Diagnostic Technology, Inc.1987-06-25
THE GOLDEN QUAD TEST (EBV) (K861121)Microbiological Research Corp.1987-02-02
INDIRECT IMMUNOFLUORESCENT ANTIBODY ASSAY/ EBV-VCA (K864347)Granbio, Inc.1987-02-02
EBV/VCA-CHECK(TM) ANTIGEN SLIDES (K863408)Diagnostic Technology, Inc.1986-11-28
EBV(EPSTEIN-BARR VIRUS) TEST KIT (K854207)Immuno-Diagnostic Products, Inc.1986-04-24
INDIRECT ENZYME LINKED IMMUNOSORBENT ASSAY IGG ANT (K853484)Biotech Research Laboratories, Inc.1986-02-05
ANTI-EPSTEIN-BARR VIRUS KIT (K842662)Amico Lab, Inc.1985-12-12
AMIZYME-EBV TEST KIT (K842530)Amico Lab, Inc.1985-12-06
ENI ANTIBODY TO EPSTEIN-BARR VIRUS (K810860)Electro-Nucleonics Laboratories, Inc.1981-05-05
EBV TEST (K771062)Gull Laboratories, Inc.1977-07-14

Track GNP automatically

Every clearance here is in the API, with alerts when new ones post.