FDA 510(k)

Solana HSV 1+2/VZV Assay

K-Number: K162451 · 2016-11-28

Decision Date2016-11-28

Product CodePGI

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

Solana HSV 1+2/VZV Assay is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2016-11-28 under approval number K162451. 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 Solana HSV 1+2/VZV Assay?

Solana HSV 1+2/VZV Assay is a medical device that received FDA 510(k) clearance on 2016-11-28. It is manufactured by Quidel Corporation. The 510(k) number is K162451.

When was Solana HSV 1+2/VZV Assay approved by the FDA?

Solana HSV 1+2/VZV Assay received FDA 510(k) clearance on 2016-11-28, under approval number K162451.

What company makes Solana HSV 1+2/VZV Assay?

Solana HSV 1+2/VZV Assay is manufactured by Quidel Corporation.

What is the FDA product code for Solana HSV 1+2/VZV Assay?

The FDA product code for Solana HSV 1+2/VZV Assay is PGI.

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Related Devices (Code: PGI)

K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup K173798Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackDiasorin Molecular, LLC K192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLC K232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentQuidel Corporation K233349Alinity m HSV 1 & 2 / VZVAbbott Molecular, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.