QIAstat-Dx GI Panel 2 Mini B&V
K-Number: K243813 · 2025-01-08
Device Summary
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. The listed applicant is QIAGEN GmbH. The 510(k) number is K243813.
When did QIAstat-Dx GI Panel 2 Mini B&V receive FDA 510(k) clearance?
QIAstat-Dx GI Panel 2 Mini B&V received FDA 510(k) clearance on 2025-01-08, under 510(k) number K243813.
Who is the listed applicant for QIAstat-Dx GI Panel 2 Mini B&V?
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 GI Panel 2 Mini B&V?
The FDA product code for QIAstat-Dx GI Panel 2 Mini B&V is PCH.
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.
Related Devices (Code: PCH)
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.
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.