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FDA 510(k)

ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS

K-Number: K931443 · 1993-11-05

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1993-11-05
Product CodeLSE
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1993-11-05 under 510(k) number K931443. The device is classified under product code LSE. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS?

ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS is a medical device that received FDA 510(k) clearance on 1993-11-05. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K931443.

When did ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS receive FDA 510(k) clearance?

ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS received FDA 510(k) clearance on 1993-11-05, under 510(k) number K931443.

Who is the listed applicant for ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS?

The FDA 510(k) record lists Ortho Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS?

The FDA product code for ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS is LSE.

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Other records listing Ortho Diagnostic Systems, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATEK951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATEK963902QUANTITATIVE FIBRINOGEN ASSAYK950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)

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Related Devices (Code: LSE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233606ADVIA Centaur EBV-VCA IgMBiokit, S.A.K162961LIAISON® VCA IgG and LIAISON® VCA IgG Serum Control Set; LIAISON® EBNA IgG and LIAISON® EBNA IgG Serum Control SetDiaSorin, Inc.K162959LIAISON® EA IgG and LIAISON® EA IgG Serum Control SetDiaSorin, Inc.K091260SERAQUEST EBV EA-D IGG TESTQuest Intl., Inc.K073382PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500GFocus Diagnostics, Inc.K062213BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEMBio-Rad Laboratories, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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