Roche Molecular Systems, Inc.

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Description

9 dispositivos en la base de datos

  • Modelo / Serial
    Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
  • Descripción del producto
    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
  • Modelo / Serial
    Lot W08792, Lot W11783, Lot W11438, Lot W14903, Lot W05108. Lot W11435, Lot W12238
  • Clasificación del producto
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Foriegn Distribution Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom cfDNA: Austria, Belgium, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary , Italy, Lithuania, Luxembourg, Netherlands, Poland, Romania, Slovakia, Slovenia, Spain, Switzerland, Turkey, United Kingdom
  • Descripción del producto
    cobas EGFR Mutation Test V2 || Materials number || CE-IVD: EGFR v2: 07248563190 || cfDNA: 07247737190 || Device Identifier: || EGFR v2.0: 00875197005448 || cfDNA: 00875197005424 || Product Usage: || A real time PCR Test for the qualitative detection and identifications of mutations n exons 18, 19, 20 and 21 of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) tumor tissue or plasma from non-small cell lung cancer (NSCLC) patients. The test also is intended to be used as an aid in selecting patients with NSCLC for therapy with an EGFR tyrosine kinase inhibitor (TKI).
  • Modelo / Serial
    Device Identifier: 07613336106174
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of: CA, GA, HI, IN, MD, ME, MI, MN, NC, NY, PA, VI, and WI. The products were distributed to the following foreign countries: Austria, Belgium, Brazil, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, France, Germany, Guatemala, Hong Kong, Hungary, India, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Singapore, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, UAE, United Kingdom, Vietnam.
  • Descripción del producto
    MagNA Pure 24 System, GMMI: 07290519001 || Product Usage: || The MagNA Pure 24 System is a fully automated clinical sample extractor. It extracts nucleic acids from various sample types, sample tubes, and volume inputs for multiple downstream applications. The main features of the system are : Scalable purification of 1 to 24 samples Primary/secondary tube handling Inventory and sample management via barcodes Efficient order management via host The MagNA Pure 24 System offers 4 run types: Purification (rack) run Purification (cartridge) run Post Elution run Sample transfer run
  • Modelo / Serial
    38161611
  • Clasificación del producto
  • Clase de dispositivo
    Not Classified
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    LightMix¿ Zika rRT-PCR Test || The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. ¿263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. Results are for the identification of Zika virus RNA. Zika virus RNA is generally detectable in serum during the acute phase of infection (approximately 7 days following onset of symptoms, if present). Positive results are indicative of current infection. Laboratories are required to report all positive results to the appropriate public health authorities. Within the United States and its territories positive results must be reported to appropriate state/local public health authorities. Negative results do not preclude Zika virus infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. The LightMix¿ Zika rRT-PCR Test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of realtime PCR and in vitro diagnostic procedures. The Test is only for use under the Food and Drug Administration s Emergency Use Authorization.
  • Modelo / Serial
    Lot Numbers: 51222E, 60121H, 60201D, and 60229F
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
  • Descripción del producto
    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
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8 fabricantes con un nombre similar

Más información acerca de la data acá

  • Dirección del fabricante
    Roche Molecular Systems, Inc., 1080 Us Highway 202 S, Branchburg NJ 08876-3733
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    Roche Molecular Systems, Inc., 1080 US Highway 202 South, Somerville NJ 08876-3733
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA
  • Dirección del fabricante
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Somerville NJ 08876-3733
  • Source
    USFDA
3 más