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FDA 510(k)

QIAstat-Dx Meningitis/Encephalitis (ME) Panel

K-Number: K242256 · 2024-10-29

ApplicantQIAGEN GmbH
Decision Date2024-10-29
Product CodePLO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QIAstat-Dx Meningitis/Encephalitis (ME) Panel is the device name listed in this FDA 510(k) record. The listed applicant is QIAGEN GmbH. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K242256. The device is classified under product code PLO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QIAstat-Dx Meningitis/Encephalitis (ME) Panel?

QIAstat-Dx Meningitis/Encephalitis (ME) Panel is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is QIAGEN GmbH. The 510(k) number is K242256.

When did QIAstat-Dx Meningitis/Encephalitis (ME) Panel receive FDA 510(k) clearance?

QIAstat-Dx Meningitis/Encephalitis (ME) Panel received FDA 510(k) clearance on 2024-10-29, under 510(k) number K242256.

Who is the listed applicant for QIAstat-Dx Meningitis/Encephalitis (ME) Panel?

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

What is the FDA product code for QIAstat-Dx Meningitis/Encephalitis (ME) Panel?

The FDA product code for QIAstat-Dx Meningitis/Encephalitis (ME) Panel is PLO.

Other records listing QIAGEN GmbH 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: PLO)

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.

K190219Simplexa VZV Direct, Simplexa VZV Positive Control PackDiasorin Molecular, LLCK160462FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray TorchBiofire Diagnostics, 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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