QIAGEN GmbH

PMA#

• therascreen KRAS RGQ PCR Kit

  2022-07-11

  QIAGEN GmbHqiagen Strasse 1hilden 40724 PMA NumberP110027 Supplement NumberS015 Date Received06/15/2022 Decision Date07/11/2022 Product Code OWD  Advisory Committee Pathology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/steri...

• therascreen KRAS RGQ PCR Kit

  2022-06-17

  QIAGEN GmbHqiagen Strasse 1hilden 40724 PMA NumberP110027 Supplement NumberS014 Date Received05/19/2022 Decision Date06/17/2022 Product Code OWD  Advisory Committee Pathology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indic...

• therascreen FGFR RGQ RT-PCR Kit

  2021-11-16

  QIAGEN GmbH

• therascreen EGFR RGQ PCR Kit

  2021-07-07

  QIAGEN GmbH

• therascreen KRAS RGQ PCR KIT

  2021-05-28

  QIAGEN GmbH

• therascreen BRAF V600E RGQ PCR Kit

  2020-04-15

  QIAGEN GmbH

• therascreen KRAS RGQ PCR Kit

  2020-04-03

  QIAGEN GmbH

• therascreen EGFR RGQ PCR Kit

  2020-04-03

  QIAGEN GmbH

• therascreen FGFR RGQ PCR Kit

  2020-04-03

  QIAGEN GmbH

• therascreen PIK3CA RGQ PCR Kit

  2020-04-03

  QIAGEN GMBH

• therascreen PIK3CA RGQ PCR Kit

  2019-05-24

  QIAGEN GMBH

• therascreen PIK3CA PLASMA RGQ PCR Kit

  2019-05-24

  QIAGEN GmbH

• therascreen FGFR RGQ RT-PCR Kit

  2019-04-12

  QIAGEN GmbH

PMN#

• QIAstat-Dx GI Panel 2 Mini B&V

  2025-01-08

  QIAGEN GmbH

• QIAstat-Dx Meningitis/Encephalitis (ME) Panel

  2024-10-29

  QIAGEN GmbH

• QIAstat-Dx Respiratory Panel Mini

  2024-10-25

  QIAGEN GmbH

• QIAstat-Dx Gastrointestinal Panel 2

  2024-05-31

  QIAGEN GmbH

• QIAstat-Dx® Respiratory Panel Plus

  2024-05-10

  QIAGEN GmbH

• QIAstat-Dx Respiratory Panel

  2019-05-18

  QIAGEN GmbH

GUDID#

• EZ2 Connect MDx - The EZ2 Connect MDx is a compact benchtop instrument for automated isolation of nucleic acids from up to 24 samples in parallel, using sealed prefilled cartridgesThe EZ2 Connect MDx system is designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. The EZ2 Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the EZ2 Connect MDx instrument for the applications described in the kit handbooks. The EZ2 Connect MDx system is intended for use by professional operators, such as technicians and physicians trained in molecular biological techniques and the operation of the EZ2 Connect MDx system.

  QIAGEN GmbH

  2026-03-03

• QIAstat-Dx® Respiratory Panel Plus - IVD kit containing 6 tests

  QIAGEN GmbH

  2025-09-25

• QIAstat-Dx® Meningitis/Encephalitis (ME) Panel - IVD kit containing 6 tests

  QIAGEN GmbH

  2025-10-31

• QIAstat-Dx® GI Panel 2 Mini B - IVD kit containing 6 tests

  QIAGEN GmbH

  2025-03-28

• QIAstat-Dx® GI Panel 2 Mini B&V - IVD kit containing 6 tests

  QIAGEN GmbH

  2025-02-18

• QIAstat-Dx® Respiratory Panel Mini - IVD kit containing 6 tests

  QIAGEN GmbH

  2024-12-05

• QIAstat-Dx® Gastrointestinal Panel 2 - IVD kit containing 6 tests

  QIAGEN GmbH

  2024-06-17

• QIAstat-Dx® Respiratory Panel Plus - V1

  QIAGEN GmbH

  2025-09-25

• QIAstat-Dx® Respiratory Panel Plus - V1

  QIAGEN GmbH

  2024-06-17

• QIAstat-Dx® Rise - The QIAstat-Dx Rise system is intended as an in-vitro diagnostic device for use with QIAstat-Dx in-vitro diagnostic assays indicated for use with QIAstat-Dx Rise and provides full automation from sample preparation to real-time PCR detection for molecular applications. The system is designed for professional use only and it is not a device for self-testing or near-patient testing.

  QIAGEN GmbH

  2025-09-05

• CMV Primer ASR - The CMV Primer ASR contains a specific nucleic acid sequence for the amplification of cytomegalovirus (CMV). The CMV Primer ASR is designed to detect a 105 bp region of the MIE gene in the CMV genome. The DNA is synthetically derived.Analyte Specific Reagent. Analytical and performance characteristics are not established.

  QIAGEN GmbH

  2021-06-02

• CMV Probe ASR - The CMV Probe ASR contains a specific nucleic acid sequence for detection of Cytomegalovirus (CMV). The CMV Probe ASR is designed to detect a region of the MIE gene in the CMV genome. The DNA is synthetically derived.Analyte Specific Reagent. Analytical and performance characteristics are not established.

  QIAGEN GmbH

  2021-06-02

• QIAcuityDx® Four - The QIAcuityDx® Four is an automated digital PCR (dPCR) instrument designed to perform amplification, detection (qualitative and quantitative), and analysis of nucleic acid samples, isolated from biological specimens. The QIAcuityDx® Four is to be used by trained personnel in a professional laboratory environment.

  QIAGEN GmbH

  2024-09-30

• QIAstat-Dx Analyzer 2.0 - The QIAstat-Dx Analyzer 2.0 platform is intended as an in vitro diagnostic device for use with QIAstat-Dx assays and provides full automation from sample preparation to real-time PCR detection for molecular applications.

  QIAGEN GmbH

  2024-09-18

• QIAstat-Dx® Analyzer 1.0 - Additional Catalog Numbers:9002814 QIAstat-Dx Analytical Module9002813 QIAstat-Dx Operational ModuleDI Numbers:QIAstat-Dx Analytical Module DI Number: 04053228033929QIAstat-Dx Operational Module DI Number: 04053228033936

  QIAGEN GmbH

  2019-05-24

• Rotor-Gene® Q MDx - 1

  QIAGEN GmbH

  2016-09-24

• therascreen® BRAF RGQ PCR Kit - The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene using genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) human colorectal cancer (CRC) tumor tissue. The therascreen BRAF V600E RGQ PCR Kit is an in vitro diagnostic device intended to be used as an aid in selecting patients with metastatic colorectal cancer (mCRC) whose tumors carry the BRAF V600E mutation for treatment with BRAFTOVI (encorafenib) in combination with cetuximab. The therascreen BRAF V600E RGQ PCR Kit is for use on the Rotor-Gene Q MDx (US)instrument. The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use.

  QIAGEN GmbH

  2020-06-11

• QIAcuityDx® Universal MasterMix Kit - The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagent set for use with the QIAcuityDx® Four in conjunction with associated assay specific reagents as part of validated diagnostic test procedures.The QIAcuityDx® Universal MasterMix Kit is intended for in vitro diagnostic use.The QIAcuityDx® Universal MasterMix Kit is not an automated device and is intended for laboratory use by trained personnel.It is the user’s responsibility to validate system performance for any procedures used in their laboratory which are not covered by the QIAGEN performance studies.

  QIAGEN GmbH

  2024-09-30

• QIAcuityDx® Universal MasterMix Kit - The QIAcuityDx® Universal MasterMix Kit is a ready-to-use general purpose dPCR MasterMix reagent set for use with the QIAcuityDx® Four in conjunction with associated assay specific reagents as part of validated diagnostic test procedures.The QIAcuityDx® Universal MasterMix Kit is intended for in vitro diagnostic use.The QIAcuityDx® Universal MasterMix Kit is not an automated device and is intended for laboratory use by trained personnel.It is the user’s responsibility to validate system performance for any procedures used in their laboratory which are not covered by the QIAGEN performance studies.

  QIAGEN GmbH

  2024-09-30

• QIAstat-Dx® Respiratory Panel - V1

  QIAGEN GmbH

  2019-05-24

• therascreen® PDGFRA RGQ PCR Kit - The QIAGEN therascreen® PDGFRA RGQ PCR Kit is a realtime qualitative in vitro diagnostic assay for the detection of the D842V somatic mutation in the PDGFRA gene using genomic DNA extracted from Gastrointestinal Stromal Tumor (GIST) patient’s formalin-fixed paraffin-embedded (FFPE) tumor tissue.The therascreen PDGFRA RGQ PCR Kit is intended for use as a companion diagnostic test, to aid clinicians in identification of patients with GIST who may be eligible for treatment with AYVAKIT™ (avapritinib) based on a PDGFRA mutation detected result. FFPE tumor specimens are processed using the QIAamp® DSP DNA FFPE Tissue Kit for manual sample preparation and the Rotor-Gene® Q (RGQ) MDx instrument for automated amplification and detection.

  QIAGEN GmbH

  2024-12-10

• QIAGEN Buffer ASL® - Stool Lysis Buffer

  QIAGEN GmbH

  2024-09-30

• QIAsymphony® DSP Circulating DNA Maxi Kit (192) - 1

  QIAGEN GmbH

  2024-09-30

• QIAsymphony® DSP Circulating DNA Kit (96) - 1

  QIAGEN GmbH

  2024-09-30

• QIAcuityDx® Nanoplate 26k 24-well - The QIAcuity® Nanoplate 26k 24-well is a single use disposable that partitions samples and reaction mixes using a microfluidic plate-based technology to enable the QIAcuityDx® Four to be used as intended. The QIAcuity® Nanoplate 26k 24-well is used in conjunction with the QIAcuity® Nanoplate Seals, QIAcuity® Nanoplate Tray, and the QIAcuity® Roller to establish a closure to allow air displacement to push samples into the partitioning area of the QIAcuity® Nanoplate 26k 24-well during priming.The QIAcuity® Nanoplate 26k 24-well is intended for in vitro diagnostic use.The QIAcuityDx Nanoplate is not an automated device.

  QIAGEN GmbH

  2024-09-30

• QIAensemble Decapper System - 1

  QIAGEN GmbH

  2017-08-15

• QIAsymphony® DSP Circulating DNA Kit - 2

  QIAGEN GmbH

  2022-12-07

• RNeasy® DSP FFPE Kit - 2

  QIAGEN GmbH

  2022-12-07

• QIAsymphony® DSP DNA Midi Kit - 2

  QIAGEN GmbH

  2022-12-07

• QIAsymphony® DSP DNA Mini Kit - 2

  QIAGEN GmbH

  2022-12-07

• QIAsymphony® DSP Virus/Pathogen Midi Kit - 2

  QIAGEN GmbH

  2022-12-07

• QIAsymphony® DSP Virus/Pathogen Mini Kit - 2

  QIAGEN GmbH

  2022-12-07

• EZ1® DSP Virus Kit - 5

  QIAGEN GmbH

  2022-12-07

• EZ1® DSP DNA Blood Kit - 4

  QIAGEN GmbH

  2022-12-07

• QIAamp® DSP Virus Spin Kit - 2

  QIAGEN GmbH

  2022-12-07

• QIAamp DSP Circulating NA Kit (50) - 2

  QIAGEN GmbH

  2022-12-07

• QIAamp® DSP DNA Blood Mini Kit - 3

  QIAGEN GmbH

  2022-12-07

• QIAamp® DSP Virus Kit - 2

  QIAGEN GmbH

  2022-12-07

• QIAamp® DSP DNA FFPE Tissue Kit - 2

  QIAGEN GmbH

  2022-12-07

• QIAcube Connect MDx - The QIAcube Connect MDx system is a fully automated, sample preparation system, processing up to 12 samples using silica spin columns technology. The QIAcube Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the QIAcube Connect MDx system for the protocols described in the instructions for use of the respective kits. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAcube Connect IVD system.

  QIAGEN GmbH

  2022-08-31

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