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FDA 510(k)

FIAX TEST KIT FOR HERPES SIMPLEX VIRUS

K-Number: K792559 · 1980-03-03

ApplicantIntl. Diagnostic Technology
Decision Date1980-03-03
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FIAX TEST KIT FOR HERPES SIMPLEX VIRUS is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Diagnostic Technology. It received FDA 510(k) clearance on 1980-03-03 under 510(k) number K792559. 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 FIAX TEST KIT FOR HERPES SIMPLEX VIRUS?

FIAX TEST KIT FOR HERPES SIMPLEX VIRUS is a medical device that received FDA 510(k) clearance on 1980-03-03. The listed applicant is Intl. Diagnostic Technology. The 510(k) number is K792559.

When did FIAX TEST KIT FOR HERPES SIMPLEX VIRUS receive FDA 510(k) clearance?

FIAX TEST KIT FOR HERPES SIMPLEX VIRUS received FDA 510(k) clearance on 1980-03-03, under 510(k) number K792559.

Who is the listed applicant for FIAX TEST KIT FOR HERPES SIMPLEX VIRUS?

The FDA 510(k) record lists Intl. Diagnostic Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIAX TEST KIT FOR HERPES SIMPLEX VIRUS?

The FDA product code for FIAX TEST KIT FOR HERPES SIMPLEX VIRUS is GQL.

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Other records listing Intl. Diagnostic Technology 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.

K850591FIAX TOXO-M ANTIBODIES TEST KITK843570FIAX HAPTOGLOBIN TEST KITK843621FIAX 420 DILUTORK843356FIAX 100 FLUOROMETERK842749FIAX TOTAL IGE TEST KITK842071FIAX TRANSFERRIN TEST KIT

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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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