Atlas FDA

LJN

23 FDA 510(k) clearances · Product code

141 daysmedian time to decision
299 days90th percentile
23clearances measured

FDA profile

Official device name
Antibody Igm, If, Epstein-Barr Virus
Device class
Class I (low risk)
Regulation
21 CFR 866.3235
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
1994: 1 · 1995: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BIOPLEX 2200 EBV IGM KIT (K123021)Bio-Rad Laboratories2012-11-02
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M (K073381)Focus Diagnostics, Inc.2008-08-04
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM (K042092)Zeus Scientific, Inc.2005-04-12
MODIFICATION TO SERAQUEST VCA IGM (K033780)Quest Intl., Inc.2004-01-15
SERAQUEST EB VAC IGM (K990977)Quest Intl., Inc.1999-10-06
COPALIS EBV-M ANTIBODY ASSAY (K991459)DiaSorin, Inc.1999-05-14
IMMUNOWELL VCA IGM TEST (K973939)Genbio1998-08-10
EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY (K931520)Mrl Diagnostics1994-04-26
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA (K930020)Ortho Diagnostic Systems, Inc.1993-07-16
BARTELS EPSTEIN-BARR VIRUS IGM EIA (K922331)Baxter Diagnostics, Inc.1992-09-02
EBV-VCA IGM ELISA (K915348)Pharmacia Diagnostics, Inc.1992-02-14
AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST (K911362)Amico Laboratories, Inc.1991-10-07
EBV IGM ELISA TEST (K910042)Gull Laboratories, Inc.1991-02-21
(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM (K901840)Granbio, Inc.1990-09-12
EBV VCA ANTIBODY (IGM) (K896594)Hillcrest Biologicals1990-01-16
BION EBV-M (VCA) TEST SYSTEM (K893240)Bion Ent., Ltd.1989-07-14
RESUBMITTED EBV/IGM-CHECK TEST KIT (K890639)Diagnostic Technology, Inc.1989-06-20
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME) (K880884)Immuno Concepts, Inc.1988-08-30
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT) (K880886)Immuno Concepts, Inc.1988-08-30
DU PONT VCA-IGM ANTIBODY ELISA KIT (K875204)E.I. Dupont DE Nemours & Co., Inc.1988-07-08
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO. (K872541)Ortho Diagnostic Systems, Inc.1988-05-13
EBV VCA IGM ANTIBODY ASSAY KIT (K864604)Granbio, Inc.1987-02-02
EBV-VCA-IGM IFA TEST SYSTEM (K833014)Zeus Scientific, Inc.1983-12-27

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