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FDA 510(k)

Solana HSV 1+2/VZV Assay

K-Number: K162451 · 2016-11-28

ApplicantQuidel Corporation
Decision Date2016-11-28
Product CodePGI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Solana HSV 1+2/VZV Assay is the device name listed in this FDA 510(k) record. The listed applicant is Quidel Corporation. It received FDA 510(k) clearance on 2016-11-28 under 510(k) 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. The listed applicant is Quidel Corporation. The 510(k) number is K162451.

When did Solana HSV 1+2/VZV Assay receive FDA 510(k) clearance?

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

Who is the listed applicant for Solana HSV 1+2/VZV Assay?

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

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.

Other records listing Quidel Corporation 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.

K231795QuickVue COVID-19 TestK232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentK233688Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetK230349Lyra RSV+hMPV AssayK230236Lyra Influenza A+B AssayK211342Sofia 2 Campylobacter FIA

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Related Devices (Code: PGI)

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.

K233349Alinity m HSV 1 & 2 / VZVAbbott Molecular, Inc.K232286Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna InstrumentQuidel CorporationK192376Simplexa VZV Swab Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLCK180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroupK173798Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackDiasorin Molecular, LLC

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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