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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...

PMN#

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

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

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

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

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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