Atlas FDA

QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini

FDA 510(k) clearance K250080 · decided 2025-08-27

Clearance details

K-number
K250080
Device name
QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini
Applicant
QIAGEN GmbH
Decision
Substantially Equivalent
Date received
2025-01-13
Decision date
2025-08-27
Days to decision
226 days
Clearance type
Traditional
Product code
QOF
Device class
2
Regulation number
866.3981
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Hilden, DE
Third-party review
No
Expedited review
No

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cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (K243406)Roche Molecular Systems, Inc.2025-04-25
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (K243400)Roche Molecular Systems, Inc.2025-04-25
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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