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FDA 510(k)

ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA

K-Number: K930002 · 1993-07-16

ApplicantOrtho Diagnostic Systems, Inc.
Decision Date1993-07-16
Product CodeLLM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA 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 1993-07-16 under 510(k) number K930002. 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 ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA?

ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA is a medical device that received FDA 510(k) clearance on 1993-07-16. The listed applicant is Ortho Diagnostic Systems, Inc.. The 510(k) number is K930002.

When did ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA receive FDA 510(k) clearance?

ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA received FDA 510(k) clearance on 1993-07-16, under 510(k) number K930002.

Who is the listed applicant for ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA?

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 EBNA-IFF ANTIBODY ELISA?

The FDA product code for ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA 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 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: 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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