QIAGEN GmbH

Address:QIAGEN STRASSE 1,HILDEN North Rhine-Westphalia,DE

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Reagents, Specific, Analyte (MVU) (1) Somatic Gene Mutation Detection System (OWD) (1)

Premarket Exempt

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CMV Probe ASR - 04053228040996 Catalog Number : 1124264

Device Description : The CMV Probe ASR contains a specific nucleic acid sequence for detection of Cyt 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.

Device Class : 1

Duns Number: 317103745

Premarket Exempt : Yes

Product Code : MVU

Prescription Use : Yes

Device Count : 1

therascreen® FGFR RGQ RT-PCR Kit - 04053228043560 Catalog Number : 874721

Device Description : The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR te The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib).Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.

Device Class : 3

Duns Number: 317103745

Premarket Exempt : No

Product Code : OWD

Prescription Use : Yes

Device Count : 1

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