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FDA 510(k)

CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM

K-Number: K811671 · 1981-09-16

ApplicantZeus Scientific, Inc.
Decision Date1981-09-16
Product CodeGQH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM 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 1981-09-16 under 510(k) number K811671. The device is classified under product code GQH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM?

CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1981-09-16. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K811671.

When did CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM receive FDA 510(k) clearance?

CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM received FDA 510(k) clearance on 1981-09-16, under 510(k) number K811671.

Who is the listed applicant for CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM?

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 CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM?

The FDA product code for CYTOMEGALOVIRUS ANTIBODY TEST SYSTEM is GQH.

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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 dIFineK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK190907ZEUS 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 SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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Related Devices (Code: GQH)

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.

K982311BARTELS CINAKIT CMV ANTIGENEMIAIntracel Corp.K964875CMV ANTIGEN CONTROL SLIDESViral Antigens, Inc.K935809CYTOMEGALOVIRUS INDIRECT IMMUNOFLUORESCENCE ASSAYLight DiagnosticsK882835INDIRECT FLUORESCENT ASSAY FOR (HCMV)Stellar Bio Systems, Inc.K882024FITC MURINE MONOCLONAL ANTI-CMV IGGWhittaker Bioproducts, Inc.K881932ORTHO* CYTOMEGALOVIRUS IDENTIFICATION REAGENTOrtho Diagnostic Systems, 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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