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FDA 510(k)

EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST

K-Number: K933251 · 1994-06-13

ApplicantVirion (U.S.), Inc.
Decision Date1994-06-13
Product CodeMCD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST is the device name listed in this FDA 510(k) record. The listed applicant is Virion (U.S.), Inc.. It received FDA 510(k) clearance on 1994-06-13 under 510(k) number K933251. The device is classified under product code MCD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST?

EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST is a medical device that received FDA 510(k) clearance on 1994-06-13. The listed applicant is Virion (U.S.), Inc.. The 510(k) number is K933251.

When did EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST receive FDA 510(k) clearance?

EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST received FDA 510(k) clearance on 1994-06-13, under 510(k) number K933251.

Who is the listed applicant for EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST?

The FDA 510(k) record lists Virion (U.S.), Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST?

The FDA product code for EPSTEIN-BARR VIRUS COMBI TEST, EBV COMBI TEST is MCD.

Related Clinical Trials

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.

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Other records listing Virion (U.S.), 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.

K921618COXSACKIE VIRUS B1-B6 CF ANTIGENSK905306MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGENK905385P.I.V. COMPLEMENT-FIXATION (C.F.) ANTIGENK864981TOXOPLASMA GONDII

Related Devices (Code: MCD)

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.

K984126THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K925689MERIDIAN EBV-IGG TEST KITFuller Laboratories, Inc.K924091EBV-VCA IGG ELISA TEST SYSTEMZeus Scientific, Inc.K920412MODIFIED ORTHO EBV VCA-IGG ELISAOrtho Diagnostic Systems, Inc.K911571EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TESTOrtho Diagnostic Systems, Inc.K911570EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TESTOrtho Diagnostic Systems, Inc.

Official Source

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

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