ClearanceBrief
Company

Qiagen Sciences LLC

FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.

0510(k) clearances (0 in 12 months)
23recalls (0 in 12 months)
4recalls that name a 510(k)

Product codes

CodeDeviceRecords
JJHClinical Sample Concentrator6
OWDSomatic Gene Mutation Detection System6
QLTCovid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices3
NQMImmunoassay For Detection Of Amniotic Fluid Protein(S).2
NCDTest, Immunity, Cell Mediated, Mycobacterium Tuberculosis1
NTWSystem, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test1
OOIReal Time Nucleic Acid Amplification System1
OWG1
QKPCoronavirus Antigen Detection Test System.1
QOFMulti-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Mar 31, 2025Qiagen Sciences LLC
Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224 Software Version: n/a Component: n/a
Open, Classified
QOFK233100
Jul 12, 2024Qiagen Sciences LLC
QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 9003
Open, Classified
JJHNone listed
Apr 10, 2024Qiagen Sciences LLC
EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230
Open, Classified
JJHNone listed
Jun 2, 2023Qiagen Sciences LLC
QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
Open, Classified
QLTNone listed
Jul 20, 2022Qiagen Sciences LLC
FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
Open, Classified
OWDNone listed
Jul 20, 2022Qiagen Sciences LLC
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
Open, Classified
OWDNone listed
Jul 20, 2022Qiagen Sciences LLC
therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
Open, Classified
OWDNone listed
Feb 25, 2022Qiagen Sciences LLC
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
Open, Classified
OWDNone listed
Feb 25, 2022Qiagen Sciences LLC
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Open, Classified
OWDNone listed
Nov 21, 2021Qiagen Sciences LLC
QIAcube Connect MDx, Model No. 9003070
Open, Classified
JJHNone listed
Nov 8, 2021Qiagen Sciences LLC
QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
Terminated
QLTNone listed
Jan 15, 2021Qiagen Sciences LLC
SARS-CoV-2 Antigen Test
Terminated
QKPNone listed
Dec 11, 2020Qiagen Sciences LLC
therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected r
Terminated
OWDNone listed
Jul 15, 2020Qiagen Sciences LLC
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and differentiation of nucleic acid from multiple respiratory viral an
Terminated
QLTNone listed
Apr 8, 2020Qiagen Sciences LLC
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
Terminated
OWGNone listed
Feb 21, 2020Qiagen Sciences LLC
AmniSure ROM Test, Material Nos. FMRT-1-25-US (US Distribution, 25 tests/box), FMRT-1-10-US (US Distribution, 10 tests/box), FMRT-1-25-CA (Canadian Distribution; 25 tests/box)
Terminated
NQMK081767
Jan 28, 2020Qiagen Sciences LLC
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
Terminated
OOIK113319
Aug 1, 2019Qiagen Sciences LLC
Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation
Terminated
JJHNone listed
Jul 2, 2019Qiagen Sciences LLC
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Pro
Open, Classified
JJHNone listed
May 6, 2019Qiagen Sciences, Inc.
RNeasy DSP FFPE Kit (48), REF 73604 - Product Usage: The RNeasy DSP FFPE Kit is a system intended for the purification of total RNA from formalin-fixed, paraffin embedded (FFPE) tissues. The product i
Terminated
NTWNone listed
Jul 23, 2018Qiagen Sciences LLC
EZ1 Advanced XL, Model Number: 9001492, GTIN: 04053228010760 Product Usage: The EZ1 Advanced XL is designed to perform automated isolation and purification of nucleic acids. It is intended to be used
Terminated
JJHNone listed
Jul 13, 2018Qiagen Sciences, Inc.
AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog Number FMRT-1-25-CA Product Usage: Rapid, non-instrumented, qualitative immunochromatographic test for the in
Terminated
NQMK081767
Feb 2, 2016Qiagen Sciences LLC
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
Terminated
NCDNone listed
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