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FDA 510(k)

LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG

K-Number: K081687 · 2008-11-10

ApplicantDiaSorin, Inc.
Decision Date2008-11-10
Product CodeMYF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG is the device name listed in this FDA 510(k) record. The listed applicant is DiaSorin, Inc.. It received FDA 510(k) clearance on 2008-11-10 under 510(k) number K081687. The device is classified under product code MYF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG?

LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG is a medical device that received FDA 510(k) clearance on 2008-11-10. The listed applicant is DiaSorin, Inc.. The 510(k) number is K081687.

When did LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG receive FDA 510(k) clearance?

LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG received FDA 510(k) clearance on 2008-11-10, under 510(k) number K081687.

Who is the listed applicant for LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG?

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

What is the FDA product code for LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG?

The FDA product code for LIAISON HSV-2 TYPE SPECIFIC IGG ASSAY, CONTROL HSV-2 IGG is MYF.

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Related Devices (Code: MYF)

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.

K243575ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsBiokit, S.A.K220924Elecsys HSV-2 IgG (08948887160)Roche DiagnosticsK181514SeraQuest HSV Type 2 Specific IgGQuest International, Inc.K181334ADVIA Centaur Herpes-2 IgGBiokit, S.A.K152353SeraQuest HSV Type 2 Specific IgGQuest International, Inc.K103603ZEUS ELISA HSV GG-2 IGG TEST SYSTEMZeus Scientific, 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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