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FDA 510(k)

HERPES VIRUS HOMINIS ANTIBODY TEST SYS.

K-Number: K812085 · 1981-09-01

ApplicantZeus Scientific, Inc.
Decision Date1981-09-01
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

HERPES VIRUS HOMINIS ANTIBODY TEST SYS. 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 1981-09-01 under 510(k) number K812085. The device is classified under product code GQL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HERPES VIRUS HOMINIS ANTIBODY TEST SYS.?

HERPES VIRUS HOMINIS ANTIBODY TEST SYS. is a medical device that received FDA 510(k) clearance on 1981-09-01. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K812085.

When did HERPES VIRUS HOMINIS ANTIBODY TEST SYS. receive FDA 510(k) clearance?

HERPES VIRUS HOMINIS ANTIBODY TEST SYS. received FDA 510(k) clearance on 1981-09-01, under 510(k) number K812085.

Who is the listed applicant for HERPES VIRUS HOMINIS ANTIBODY TEST SYS.?

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 HERPES VIRUS HOMINIS ANTIBODY TEST SYS.?

The FDA product code for HERPES VIRUS HOMINIS ANTIBODY TEST SYS. is GQL.

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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: GQL)

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.

K091753ELVIS HSV ID AND D3 TYPING TEST SYSTEMDiagnostic Hybrids, Inc.K081527LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KITMillipore CorporationK984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated Diagnostics, 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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