Product Code: LJN FDA class 1 21 CFR 866.3235

Antibody Igm, If, Epstein-Barr Virus

Microbiology

Antibody IgM, If, Epstein-Barr Virus is an immunofluorescence (IF) assay reagent used in clinical microbiology laboratories to detect IgM-class antibodies against Epstein-Barr Virus (EBV), aiding in the diagnosis of primary EBV infection such as infectious mononucleosis. This is an FDA Class 1 device, the lowest risk category, subject to general controls only. The product code is LJN, regulated under 21 CFR 866.3235, within the Microbiology medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: LJN
Device Class: FDA class 1
Regulation Number: 866.3235
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 23 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K123021	BIOPLEX 2200 EBV IGM KIT	Nov 02, 2012	Substantially Equivalent	Bio-Rad Laboratories
K073381	PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M	Aug 04, 2008	Substantially Equivalent	Focus Diagnostics, Inc.
K042092	ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM	Apr 12, 2005	Substantially Equivalent	Zeus Scientific, Inc.
K033780	MODIFICATION TO SERAQUEST VCA IGM	Jan 15, 2004	Substantially Equivalent	Quest Intl., Inc.
K990977	SERAQUEST EB VAC IGM	Oct 06, 1999	Substantially Equivalent	Quest Intl., Inc.
K991459	COPALIS EBV-M ANTIBODY ASSAY	May 14, 1999	Substantially Equivalent	DiaSorin, Inc.
K973939	IMMUNOWELL VCA IGM TEST	Aug 10, 1998	Substantially Equivalent	Genbio
K931520	EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY	Apr 26, 1994	Substantially Equivalent	Mrl Diagnostics
K930020	ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA	Jul 16, 1993	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K922331	BARTELS EPSTEIN-BARR VIRUS IGM EIA	Sep 02, 1992	Substantially Equivalent	Baxter Diagnostics, Inc.
K915348	EBV-VCA IGM ELISA	Feb 14, 1992	Substantially Equivalent	Pharmacia Diagnostics, Inc.
K911362	AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST	Oct 07, 1991	Substantially Equivalent	Amico Laboratories, Inc.
K910042	EBV IGM ELISA TEST	Feb 21, 1991	Substantially Equivalent	Gull Laboratories, Inc.
K901840	(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM	Sep 12, 1990	Substantially Equivalent	Granbio, Inc.
K896594	EBV VCA ANTIBODY (IGM)	Jan 16, 1990	Substantially Equivalent	Hillcrest Biologicals
K893240	BION EBV-M (VCA) TEST SYSTEM	Jul 14, 1989	Substantially Equivalent	Bion Ent., Ltd.
K890639	RESUBMITTED EBV/IGM-CHECK TEST KIT	Jun 20, 1989	Substantially Equivalent	Diagnostic Technology, Inc.
K880886	EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)	Aug 30, 1988	Substantially Equivalent	Immuno Concepts, Inc.
K880884	EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)	Aug 30, 1988	Substantially Equivalent	Immuno Concepts, Inc.
K875204	DU PONT VCA-IGM ANTIBODY ELISA KIT	Jul 08, 1988	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K872541	ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.	May 13, 1988	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K864604	EBV VCA IGM ANTIBODY ASSAY KIT	Feb 02, 1987	Substantially Equivalent	Granbio, Inc.
K833014	EBV-VCA-IGM IFA TEST SYSTEM	Dec 27, 1983	Substantially Equivalent	Zeus Scientific, Inc.