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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 a medical device manufactured by QIAGEN GmbH. It received FDA 510(k) clearance on 2024-10-29 under approval 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. It is manufactured by QIAGEN GmbH. The 510(k) number is K242256.

When was QIAstat-Dx Meningitis/Encephalitis (ME) Panel approved by the FDA?

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

What company makes QIAstat-Dx Meningitis/Encephalitis (ME) Panel?

QIAstat-Dx Meningitis/Encephalitis (ME) Panel is manufactured by QIAGEN GmbH.

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 Devices by QIAGEN GmbH

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Related Devices (Code: PLO)

K160462FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray TorchBiofire Diagnostics, LLC K190219Simplexa VZV Direct, Simplexa VZV 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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