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FDA 510(k)

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack

K-Number: K183223 · 2018-12-19

ApplicantDiasorin Molecular, LLC
Decision Date2018-12-19
Product CodeOZZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa Bordetella Direct, Simplexa Bordetella 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 2018-12-19 under 510(k) number K183223. The device is classified under product code OZZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack?

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack is a medical device that received FDA 510(k) clearance on 2018-12-19. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K183223.

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

Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack received FDA 510(k) clearance on 2018-12-19, under 510(k) number K183223.

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

The FDA product code for Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack is OZZ.

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: OZZ)

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.

K243753cobas liat Bordetella panel nucleic acid testRoche Molecular Systems, Inc.K173498Simplexa Bordetella Direct, Simplexa Bordetella Positive Control PackDiasorin Molecular, LLCK181029Solana Bordetella Complete AssayQuidel CorporationK163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File KitLuminex CorporationK170284Great Basin Bordetella Direct TestGreat Basin Scientific, 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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