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FDA 510(k)

ELVIS HSV ID AND D3 TYPING TEST SYSTEM

K-Number: K091753 · 2009-08-28

ApplicantDiagnostic Hybrids, Inc.
Decision Date2009-08-28
Product CodeGQL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ELVIS HSV ID AND D3 TYPING TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Hybrids, Inc.. It received FDA 510(k) clearance on 2009-08-28 under 510(k) number K091753. 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 ELVIS HSV ID AND D3 TYPING TEST SYSTEM?

ELVIS HSV ID AND D3 TYPING TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2009-08-28. The listed applicant is Diagnostic Hybrids, Inc.. The 510(k) number is K091753.

When did ELVIS HSV ID AND D3 TYPING TEST SYSTEM receive FDA 510(k) clearance?

ELVIS HSV ID AND D3 TYPING TEST SYSTEM received FDA 510(k) clearance on 2009-08-28, under 510(k) number K091753.

Who is the listed applicant for ELVIS HSV ID AND D3 TYPING TEST SYSTEM?

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

What is the FDA product code for ELVIS HSV ID AND D3 TYPING TEST SYSTEM?

The FDA product code for ELVIS HSV ID AND D3 TYPING TEST SYSTEM is GQL.

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Other records listing Diagnostic Hybrids, 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.

K092229THYRETAIN TM TSI REPORTER BIOASSAYK093415D3 FASTPOINT L-DFA PARAINFLUENZA VIRUS/ADENOVIRUS IDENTIFICATION KITK093233D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KITK092882D3 FASTPOINT L-DFA INFLUENZA A/INFLUENZA B VIRUS IDENTIFICATION KITK091171D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KITK092300MODIFICATION TO D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID 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.

K081527LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KITMillipore CorporationK984135THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FORZeus Scientific, Inc.K984120THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THZeus Scientific, Inc.K905608INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1Stellar Bio Systems, Inc.K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGCalifornia Integrated Diagnostics, Inc.K904167PATHODX HERPES TYPINGDiagnostic Products Corp.

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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