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FDA 510(k)

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack

K-Number: K173798 · 2018-03-14

ApplicantDiasorin Molecular, LLC
Decision Date2018-03-14
Product CodePGI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack is a medical device manufactured by Diasorin Molecular, LLC. It received FDA 510(k) clearance on 2018-03-14 under approval number K173798. 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 Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack?

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack is a medical device that received FDA 510(k) clearance on 2018-03-14. It is manufactured by Diasorin Molecular, LLC. The 510(k) number is K173798.

When was Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack approved by the FDA?

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack received FDA 510(k) clearance on 2018-03-14, under approval number K173798.

What company makes Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack?

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack is manufactured by Diasorin Molecular, LLC.

What is the FDA product code for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack?

The FDA product code for Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack is PGI.

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Other Devices by Diasorin Molecular, LLC

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Related Devices (Code: PGI)

K162451Solana HSV 1+2/VZV AssayQuidel Corporation K180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroup 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

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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