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FDA 510(k)

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit

K-Number: K260333 · 2026-06-15

ApplicantDiasorin Molecular, LLC
Decision Date2026-06-15
Product CodePGX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit is the device name listed in this FDA 510(k) record. The listed applicant is Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2026-06-15 under 510(k) number K260333. The device is classified under product code PGX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit?

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K260333.

When did LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit receive FDA 510(k) clearance?

LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit received FDA 510(k) clearance on 2026-06-15, under 510(k) number K260333.

Who is the listed applicant for LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit?

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

What is the FDA product code for LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit?

The FDA product code for LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab Kit is PGX.

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Related Devices (Code: PGX)

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.

K201269Accula Strep A TestMesa Biotech, Inc.K183366GenePOC Strep AGenepoc, Inc.K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.K173398Xpert Xpress Strep ACepheidK172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File KitLuminex CorporationK172126Xpert Xpress Strep ACepheid

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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