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FDA 510(k)

VARICELLA-ZOSTER(IGG) IFA TEST

K-Number: K841434 · 1985-04-19

ApplicantZeus Scientific, Inc.
Decision Date1985-04-19
Product CodeGQW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VARICELLA-ZOSTER(IGG) IFA TEST is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1985-04-19 under 510(k) number K841434. The device is classified under product code GQW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VARICELLA-ZOSTER(IGG) IFA TEST?

VARICELLA-ZOSTER(IGG) IFA TEST is a medical device that received FDA 510(k) clearance on 1985-04-19. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K841434.

When did VARICELLA-ZOSTER(IGG) IFA TEST receive FDA 510(k) clearance?

VARICELLA-ZOSTER(IGG) IFA TEST received FDA 510(k) clearance on 1985-04-19, under 510(k) number K841434.

Who is the listed applicant for VARICELLA-ZOSTER(IGG) IFA TEST?

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

What is the FDA product code for VARICELLA-ZOSTER(IGG) IFA TEST?

The FDA product code for VARICELLA-ZOSTER(IGG) IFA TEST is GQW.

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Other records listing Zeus Scientific, 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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Related Devices (Code: GQW)

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.

K070206DIAGNOSTIC HYBRIDS D3 DFA VARICELLA-ZOSTER VIRUS IDENTIFICATION KIT, 01-020000Diagnostic Hybrids, Inc.K990141LIGHT DIAGNOSTICS SIMULFLUOR HSV/VZV IMMUNOFLOURESCENCE ASSAY, MODEL 3295Light DiagnosticsK964872VZV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K942743VIRO VARICELLA-ZOSTER VIRUS IDENTIFICATION REAGENTViro Research, Inc.K912239VZVSCAN(TM) LATEX AGGUTINATION TESTBd Becton Dickinson Vacutainer Systems PreanalyticK903882VARICELLA-ZOSTER VIRUS ANTIBODY TEST KIT-LATEX AGGViral Antigens, 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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