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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228045793 ()
937036

  • Nucleic acid extraction/isolation kit IVD
No Description
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228045786 ()
937055

  • Nucleic acid extraction/isolation kit IVD
No Description
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228045779 ()
937236

  • Nucleic acid extraction/isolation kit IVD
No Description
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228045762 ()
937255

  • Nucleic acid extraction/isolation kit IVD
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.
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228043560 ()
874721

  • Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228031024 ()
73604

  • Nucleic acid extraction/isolation kit IVD
No Description
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228030072 ()
937556

  • Nucleic acid extraction/isolation kit IVD
No Description
QIAGEN SCIENCES INC.
2
In Commercial Distribution

  • 04053228010296 ()
5140-1220

  • Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN SCIENCES INC.
2
In Commercial Distribution

  • 04053228010265 ()
5130-1220

  • Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT)
  • Chlamydia trachomatis nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
QIAGEN GmbH
2
In Commercial Distribution

  • 04053228002895 ()
61304

  • Nucleic acid extraction/isolation kit IVD
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