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FDA 510(k)

Simplexa GBS Direct, Simplexa GBS Positive Control Pack

K-Number: K182467 · 2018-11-07

ApplicantDiasorin Molecular, LLC
Decision Date2018-11-07
Product CodeNJR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Simplexa GBS Direct, Simplexa GBS 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 2018-11-07 under 510(k) number K182467. The device is classified under product code NJR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Simplexa GBS Direct, Simplexa GBS Positive Control Pack is a medical device that received FDA 510(k) clearance on 2018-11-07. The listed applicant is Diasorin Molecular, LLC. The 510(k) number is K182467.

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

Simplexa GBS Direct, Simplexa GBS Positive Control Pack received FDA 510(k) clearance on 2018-11-07, under 510(k) number K182467.

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

The FDA product code for Simplexa GBS Direct, Simplexa GBS Positive Control Pack is NJR.

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.

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Related Devices (Code: NJR)

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.

K222638Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsCepheidK203429Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity SystemCepheidK181156Panther Fusion GBS AssayDiagenodeK173725NeuMoDx GBS AssayNeumodx Molecular, Inc.K173250Solana GBS AssayQuidel CorporationK170557GenePOC GBS LBGenepoc, 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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