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FDA 510(k)

EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST

K-Number: K911569 · 1991-06-10

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1991-06-10
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST 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 1991-06-10 under 510(k) number K911569. The device is classified under product code LLM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST?

EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST is a medical device that received FDA 510(k) clearance on 1991-06-10. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K911569.

When did EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST receive FDA 510(k) clearance?

EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST received FDA 510(k) clearance on 1991-06-10, under 510(k) number K911569.

Who is the listed applicant for EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST?

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 EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST?

The FDA product code for EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST is LLM.

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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 ASSAYK950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)K950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)

View all 126 devices →

Related Devices (Code: LLM)

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.

K233605ADVIA Centaur EBV-EBNA IgGBiokit, S.A.K040120DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYSDiaSorin, Inc.K984133THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K973941IMMUNOWELL EBNA IGG TESTGenbioK980598EBNA-1 IGM ELISA TEST SYSTEMClark Laboratories, Inc.K951549EBNA IGG EIA TEST SYSTEMImmunoprobe, 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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