36 results
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Sources: EU EUDAMED, US FDA
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Hc2 System Software Suite 4.0 version 3.0, available as component in Qiagen user guide, catalog #5050-00162, and as a component within a Qiagen PC, available as catalog # 5050-11140A. The software calculates and interprets assay results generated by the Digene Microplate Luminometer according to assay validation parameters. The software is used in conjunction with the following QIAGEN products: digene HC2 High-Risk HPV DNA Test [5199-1220 (one-plate); 5199-00016 (four-plate)] digene HC2 HPV DNA Test (5198-1220) digene HC2 CT/GC DNA Test (5130-1220) digene HC2 CT-ID DNA Test (5135-1220) digene HC2 GC-ID DNA Test (5140-1220) digene HC2 CT-GC Dual-ID DNA Test (5145-1220)
FDA Recall
Terminated
·QIAGEN Gaithersburg, Inc.·Product code JJQ·January 12, 2011
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code OOI·January 28, 2020
SARS-CoV-2 Antigen Test
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code QKP·January 15, 2021
QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).
FDA Recall
Terminated
·QIAGEN Gaithersburg, Inc.·Product code LKQ·January 30, 2013
QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.
FDA Recall
Terminated
·QIAGEN Gaithersburg, Inc.·Product code LKQ·January 30, 2013
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
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code JJH·June 5, 2019
SARS-CoV-2 Antigen Test
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·February 10, 2021
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code NCD·February 2, 2016
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
FDA Enforcement
Class I
·Terminated·Qiagen Sciences LLC·August 7, 2019
QIAGEN artus CMV RG PCR ASR (24) (Catalog number 4503223) Product Usage: The artus CMV RG PCR ASR is designed to detect and to quantify nucleic acid specific to human cytomegalovirus (CMV) using real-time PCR technology (PCR) in the Rotor-Gene 2000/3000 (RG).
FDA Enforcement
Class II
·Terminated·QIAGEN Gaithersburg, Inc.·May 22, 2013
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 only in combination with QIAGEN kits indicated for use with the EZ1 Advanced XL instrument for the applications described in the kit handbooks. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ1 Advanced XL.
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code JJH·July 23, 2018
QIAGEN artus CMV RG PCR ASR (96) (Catalog number 4503225) Product Usage: Test is intended for use in the detection and quantitation of human cytomegalovirus (CMV) specific DNA, as part of an in house validated real-time PCR assay. One service package containing the handbook.
FDA Enforcement
Class II
·Terminated·QIAGEN Gaithersburg, Inc.·May 22, 2013
QFT TB Antigen Tube. QIAGEN Sciences, LLC. The QuantiFERON TB-Gold is an indirect test for M. tuberculosis infection (including disease)
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·March 30, 2016
QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.
FDA Enforcement
Class II
·Terminated·Qiagen Sciences LLC·March 18, 2020
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 vitro detection of amniotic fluid in vaginal discharge of pregnant women.
FDA Recall
Terminated
·Qiagen Sciences, Inc.·Product code NQM·May 18, 2018
EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.
FDA Recall
Terminated
·QIAGEN
19300 GERMANTOWN RD
GERMANTOWN MD 20874 USA
KOELN Germany·Product code JJH·May 28, 2018
Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- Ref: M124. The Lyra Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider
FDA Enforcement
Class II
·Terminated·Quidel Corporation·September 22, 2021
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code OWG·April 8, 2020
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 result. REF 873121
FDA Recall
Terminated
·Qiagen Sciences LLC·Product code OWD·December 11, 2020
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
FDA Recall
Terminated
·NeuMoDx Molecular Inc·Product code QJR·May 4, 2021