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
| Code | Device | Records |
|---|---|---|
| JJH | Clinical Sample Concentrator | 6 |
| OWD | Somatic Gene Mutation Detection System | 6 |
| QLT | Covid-19 Multi-Analyte Respiratory Panel Nucleic Acid Devices | 3 |
| NQM | Immunoassay For Detection Of Amniotic Fluid Protein(S). | 2 |
| NCD | Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis | 1 |
| NTW | System, Blood Collection, Rna Stabilization, Rna Purification, Rt-Pcr Molecular Diagnostic Test | 1 |
| OOI | Real Time Nucleic Acid Amplification System | 1 |
| OWG | 1 | |
| QKP | Coronavirus Antigen Detection Test System. | 1 |
| QOF | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 31, 2025 | Qiagen 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 |
QOF | K233100 |
| Jul 12, 2024 | Qiagen 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 |
JJH | None listed |
| Apr 10, 2024 | Qiagen 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 |
JJH | None listed |
| Jun 2, 2023 | Qiagen Sciences LLC QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223 Open, Classified |
QLT | None listed |
| Jul 20, 2022 | Qiagen Sciences LLC FGFR RGQ RT-PCR Kit (RUO, not IVD)
REF 8747010 Open, Classified |
OWD | None listed |
| Jul 20, 2022 | Qiagen Sciences LLC therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US)
REF 874711 Open, Classified |
OWD | None listed |
| Jul 20, 2022 | Qiagen Sciences LLC therascreen FGFR RGQ RT-PCR kit (US IVD)
REF 874721 Open, Classified |
OWD | None listed |
| Feb 25, 2022 | Qiagen Sciences LLC therascreen KRAS RGQ PCR Kit (24)
REF 874052 (Japan IVD, not released in the USA) Open, Classified |
OWD | None listed |
| Feb 25, 2022 | Qiagen Sciences LLC therascreen KRAS RGQ PCR Kit (24)
Model Number(s): REF 870021 (US IVD) Open, Classified |
OWD | None listed |
| Nov 21, 2021 | Qiagen Sciences LLC QIAcube Connect MDx, Model No. 9003070 Open, Classified |
JJH | None listed |
| Nov 8, 2021 | Qiagen Sciences LLC QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223 Terminated |
QLT | None listed |
| Jan 15, 2021 | Qiagen Sciences LLC SARS-CoV-2 Antigen Test Terminated |
QKP | None listed |
| Dec 11, 2020 | Qiagen 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 |
OWD | None listed |
| Jul 15, 2020 | Qiagen 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 |
QLT | None listed |
| Apr 8, 2020 | Qiagen Sciences LLC therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 Terminated |
OWG | None listed |
| Feb 21, 2020 | Qiagen 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 |
NQM | K081767 |
| Jan 28, 2020 | Qiagen 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 |
OOI | K113319 |
| Aug 1, 2019 | Qiagen 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 |
JJH | None listed |
| Jul 2, 2019 | Qiagen 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 |
JJH | None listed |
| May 6, 2019 | Qiagen 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 |
NTW | None listed |
| Jul 23, 2018 | Qiagen 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 |
JJH | None listed |
| Jul 13, 2018 | Qiagen 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 |
NQM | K081767 |
| Feb 2, 2016 | Qiagen Sciences LLC QFT TB Antigen Tube.
QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease) Terminated |
NCD | None listed |