510(k) clearances

QIAstat-Dx BCID GPF Plus AMR Panel

QIAGEN GmbH · Microbiology

K254194Substantially EquivalentTraditionalPAM
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
PAM
Zip code
40724
Applicant
QIAGEN GmbH
Decision date
2026-08-06
Decision code
SESE
Country code
DE
Device name
QIAstat-Dx BCID GPF Plus AMR Panel
Advisory committee
MI
Contact
Kristen Kanack
K number
K254194
Date received
2025-12-23
Review advisory committee
MI
Postal code
40724
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Gram-Positive Bacteria And Their Resistance Markers
Medical specialty description
Microbiology
Regulation number
866.3365
Device class
2
Registration number
3010749841, 3006028115, 3014553740, 3004013603, 3002773840, 3008632402
FEI number
3010749841, 3006028115, 3014553740, 3004013603, 3002773840, 3008632402
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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.