510(k) clearances

QIAstat-Dx GI Panel 2 Mini B

QIAGEN GmbH · Microbiology

K250324Substantially EquivalentSpecialPCH
Open FDA's page for this record
Third party flag
N
City
Hilden
Advisory committee description
Microbiology
Address 1
Qiagen Strasse 1
Statement or summary
Summary
Product code
PCH
Zip code
40724
Applicant
QIAGEN GmbH
Decision date
2025-02-28
Decision code
SESE
Country code
DE
Device name
QIAstat-Dx GI Panel 2 Mini B
Advisory committee
MI
Contact
Kristen Kanack
K number
K250324
Date received
2025-02-05
Review advisory committee
MI
Postal code
40724
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Medical specialty description
Microbiology
Regulation number
866.3990
Device class
2
Registration number
3002773840, 3010749841, 3004530258, 2024800, 3005360469, 3006028115, 3007420875, 3004013603, 3016838963, 3011781554, 3009613136, 3014553740, 1119779, 3002777243, 1650733, 3007799234
FEI number
3002773840, 3010749841, 3002524000, 3004530258, 2024800, 3006028115, 3007420875, 3004013603, 3016838963, 3011781554, 3009613136, 3014553740, 1119779, 3002777243, 3007799234, 3005670738
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

Join as a DoctorSell on MedGrid

Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.