Atlas FDA

QIAstat-Dx GI Panel 2 Mini B&V

FDA 510(k) clearance K243813 · decided 2025-01-08

Clearance details

K-number
K243813
Device name
QIAstat-Dx GI Panel 2 Mini B&V
Applicant
QIAGEN GmbH
Decision
Substantially Equivalent
Date received
2024-12-11
Decision date
2025-01-08
Days to decision
28 days
Clearance type
Special
Product code
PCH
Device class
2
Regulation number
866.3990
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Hilden, DE
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch QIAGEN GmbH

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
LIAISON PLEX Gastrointestinal Flex Assay (K253722)Luminex Corporation2026-05-19
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K254032)QIAGEN GmbH2026-03-09
Xpert GI Panel (K251721)Cepheid2026-01-16
QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini B (K252329)QIAGEN GmbH2025-10-22
Panther Fusion GI Bacterial Assay (K251868)Hologic2025-09-25
Panther Fusion GI Expanded Bacterial Assay (K251993)Hologic, Inc.2025-09-25
QIAstat-Dx GI Panel 2 Mini B (K250324)QIAGEN GmbH2025-02-28
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (K243885)Biofire Diagnostics, LLC2025-01-16
BioCode Gastrointestinal Pathogen Panel (GPP) (K242877)Applied BioCode, Inc.2025-01-10
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K242367)Biofire Diagnostics, LLC2024-11-07
QIAstat-Dx Gastrointestinal Panel 2 (K220062)QIAGEN GmbH2024-05-31
EasyScreen Gastrointestinal Parasite Detection Kit (K232672)Genetic Signatures Limited2024-05-29

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
therascreen® PIK3CA RGQ PCR Kit (P190001/S002)QIAGEN GmbH2025-10-22
QIAGEN therascreen® FGFR RGQ RT-PCR Kit (P180043/S007)QIAGEN GmbH2025-10-03
therascreen® KRAS RGQ PCR Kit (P110027/S018)QIAGEN GmbH2025-01-16
therascreen FGFR RGQ PCR Kit (P180043/S008)QIAGEN GmbH2024-12-06
therascreen FGFR RGQ RT-PCR Kit (P180043/S009)QIAGEN GmbH2024-10-23
therascreen® KRAS RGQ PCR Kit (P110027/S017)QIAGEN GmbH2024-06-21
therascreen FGFR RGQ RT-PCR Kit (P180043/S006)QIAGEN GmbH2023-12-22
QIAGEN therascreen® KRAS RGQ PCR Kit (P110027/S016)QIAGEN GmbH2023-10-06