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FDA 510(k)

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack

K-Number: K192376 · 2019-11-26

ApplicantDiasorin Molecular, LLC
Decision Date2019-11-26
Product CodePGI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack 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 2019-11-26 under 510(k) number K192376. 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 VZV Swab Direct, Simplexa VZV Positive Control Pack?

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack is a medical device that received FDA 510(k) clearance on 2019-11-26. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K192376.

When did Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack receive FDA 510(k) clearance?

Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack received FDA 510(k) clearance on 2019-11-26, under 510(k) number K192376.

Who is the listed applicant for Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack?

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 Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack?

The FDA product code for Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack is PGI.

Other records listing Diasorin Molecular, LLC 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.

K260333LIAISON NES Group A Strep; LIAISON NES Group A Strep Control Swab KitK251978LIAISON NES FLU A/B, RSV & COVID-19K252387Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa™ COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460)K220963Simplexa COVID-19 & Flu A/B DirectK202755Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control PackK212147Simplexa COVID-19 Direct

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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 CorporationK180559HSV 1 & 2 ELITe MGB Kit; ELITe InGeniusElitechgroupK173798Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control PackDiasorin Molecular, LLCK162451Solana 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.

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