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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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Audio Processor Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09245
In Commercial Distribution

  • 09008737092450 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09244
In Commercial Distribution

  • 09008737092443 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09243
In Commercial Distribution

  • 09008737092436 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
09242
In Commercial Distribution

  • 09008737092429 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Pack Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08265
In Commercial Distribution

  • 09008737082659 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Pack Kit
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08264
In Commercial Distribution

  • 09008737082642 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Pack
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08092
In Commercial Distribution

  • 09008737080921 ()


  • Cochlear implant/auditory brainstem implant battery
Audio Processor Battery Pack
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
08103
In Commercial Distribution

  • 09008737081034 ()


  • Cochlear implant/auditory brainstem implant battery
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)
The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Beckman Coulter, Inc.
37210
In Commercial Distribution

  • H628372101 ()
37210

  • Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
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