Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

QIAstat-Dx GI Panel 2 Mini B&V

K-Number: K243813 · 2025-01-08

ApplicantQIAGEN GmbH
Decision Date2025-01-08
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

QIAstat-Dx GI Panel 2 Mini B&V is a medical device manufactured by QIAGEN GmbH. It received FDA 510(k) clearance on 2025-01-08 under approval number K243813. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QIAstat-Dx GI Panel 2 Mini B&V?

QIAstat-Dx GI Panel 2 Mini B&V is a medical device that received FDA 510(k) clearance on 2025-01-08. It is manufactured by QIAGEN GmbH. The 510(k) number is K243813.

When was QIAstat-Dx GI Panel 2 Mini B&V approved by the FDA?

QIAstat-Dx GI Panel 2 Mini B&V received FDA 510(k) clearance on 2025-01-08, under approval number K243813.

What company makes QIAstat-Dx GI Panel 2 Mini B&V?

QIAstat-Dx GI Panel 2 Mini B&V is manufactured by QIAGEN GmbH.

What is the FDA product code for QIAstat-Dx GI Panel 2 Mini B&V?

The FDA product code for QIAstat-Dx GI Panel 2 Mini B&V is PCH.

Other Devices by QIAGEN GmbH

K183597QIAstat-Dx Respiratory Panel K242256QIAstat-Dx Meningitis/Encephalitis (ME) Panel K242353QIAstat-Dx Respiratory Panel Mini K220062QIAstat-Dx Gastrointestinal Panel 2 K233100QIAstat-Dx® Respiratory Panel Plus K252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B

View all 17 devices →

Related Devices (Code: PCH)

K160459FilmArray Gastrointestinal Panel (GI) for use with FilmArray TorchBiofire Diagnostics, LLC K152955Great Basin Shiga Toxin Direct TestGreat Basin Scientific, Inc. K170308BD MAX Extended Enteric Bacterial Panel, BD MAX SystemBecton, Dickinson and Company K183030xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc. K183023xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP)Luminex Molecular Diagnostics, Inc. K181427BD MAX Enteric Viral Panel, BD MAX InstrumentBecton, Dickinson and Company

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.

↑