FDA 510(k)

Alinity m HSV 1 & 2 / VZV

K-Number: K233349 · 2024-05-03

Decision Date2024-05-03

Product CodePGI

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Alinity m HSV 1 & 2 / VZV is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Molecular, Inc.. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K233349. The device is classified under product code PGI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Alinity m HSV 1 & 2 / VZV?

Alinity m HSV 1 & 2 / VZV is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Abbott Molecular, Inc.. The 510(k) number is K233349.

When did Alinity m HSV 1 & 2 / VZV receive FDA 510(k) clearance?

Alinity m HSV 1 & 2 / VZV received FDA 510(k) clearance on 2024-05-03, under 510(k) number K233349.

Who is the listed applicant for Alinity m HSV 1 & 2 / VZV?

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

What is the FDA product code for Alinity m HSV 1 & 2 / VZV?

The FDA product code for Alinity m HSV 1 & 2 / VZV is PGI.

Other records listing Abbott Molecular, 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.

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Related Devices (Code: PGI)

K232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentQuidel Corporation K192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup K173798Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackDiasorin Molecular, LLC K162451Solana HSV 1+2/VZV AssayQuidel Corporation

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.