Atlas FDA

QIAstat-Dx Respiratory Panel

FDA 510(k) clearance K183597 · decided 2019-05-18

Clearance details

K-number
K183597
Device name
QIAstat-Dx Respiratory Panel
Applicant
QIAGEN GmbH
Decision
Substantially Equivalent
Date received
2018-12-21
Decision date
2019-05-18
Days to decision
148 days
Clearance type
Traditional
Product code
OCC
Device class
2
Regulation number
866.3980
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
BioCode® Respiratory Pathogen Panel (RPP) (K254139)Applied BioCode, Inc.2026-05-01
NxTAG® Respiratory Pathogen Panel (K242613)Luminex Molecular Diagnostics, Inc.2024-10-02
ID NOW Influenza A & B 2 (K232775)Abbott Diagnostics Scarborough, Inc.2023-10-10
Panther Fusion AdV/hMPV/RV Assay (K231017)Hologic, Inc.2023-05-05
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (K213822)Roche Molecular Systems, Inc.2022-07-06
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System (K210234)Roche Molecular Systems, Inc.2021-02-16
Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack (K201505)Diasorin Molecular, LLC2020-08-22
cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System (K200065)Roche Molecular Systems, Inc.2020-02-10
BioCode Respiratory Pathogen Panel (RPP) (K192485)Applied BioCode, Inc.2019-12-23
NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software (K193167)Luminex Molecular Diagnostics, Inc.2019-12-11
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System (K191729)Roche Molecular Systems, Inc.2019-07-24
ID NOW Influenza A & B 2 (K191534)Abbott Diagnostics Scarborough, Inc.2019-07-11

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