Cobas

  • Modèle / numéro de série
    Lot #s: 70712A (6 kits); 70601W (76 kits); 70713A (4 kits); 70718A (50 kits); and 70809A (kits were not distributed to end users).
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. Austria, Denmark, Germany, Singapore, Netherlands, Hong Kong, and Switzerland. US product is not affected.
  • Description du dispositif
    Nucleic Acid test intended for screening for MRSA/SA. Each kit has 20 tubes. in vitro diagnostic.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
  • Société-mère du fabricant (2017)
  • Source
    USFDA

918 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Part numbers:05083435001 and 06268854001
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution including Puerto Rico and to the states of :TX, OH, TN, AZ, WA, MI and GA
  • Description du dispositif
    cobas p 512 pre-analytical system || Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis.
  • Manufacturer
  • Modèle / numéro de série
    Lot Numbers: 51222E, 60121H, 60201D, and 60229F
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of: TX, NY, OR, HI, MD, PA, NC, MA, IA, WA, OR, AK, ME, MN, VA, MT, PA, and LA.
  • Description du dispositif
    cobas¿ Liat Influenza A/B Quality Control Kit; For use with cobas¿ Liat Influenza A/B Assay.
  • Manufacturer
  • Modèle / numéro de série
    Not applicable
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    cobas p 312 Pre-Analytical System || calculator/data processing module, for clinical use || Product Usage: || The cobas p471 system is an automatic centrifuge module for centrifuging primary sample tubes, which will then be transported to the output module.
  • Manufacturer
  • Modèle / numéro de série
    Not applicable
  • Classification du dispositif
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    cobas p 471 centrifuge unit || calculator/data processing module, for clinical use || Product Usage: || The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
  • Manufacturer
913 en plus