Cobas

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

Manufacturer

  • Manufacturer Address
    Roche Molecular Systems, Inc., 1080 US Highway 202 S, Branchburg NJ 08876-3733
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

918 devices with a similar name

Learn more about the data here

  • Model / Serial
    05852170190; Lot P06778
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - including the countries of Austria, Belgium, Czech Republic, Denmark, Germany, Italy, Luxemburg, Netherlands, Poland, Slovakia, Slovenia, Spain, United Kingdom, Canada, Chile, Greenland, Hong Kong, Israel, Malaysia, New Zealand, Philippines, S. Africa, Switzerland, Taiwan and Turkey.
  • Product Description
    Cobas KRAS Mutation Test for In Vitro Diagnostic Use || Product Usage: Usage: || The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC).
  • Manufacturer
  • Model / Serial
    Lot Numbers: 11049503, 11053503, 11054503, 11525503 and 11526503.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA).
  • Product Description
    COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
  • Manufacturer
  • Model / Serial
    Material number 05985595190; Lot number R03607
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - Australia, Austria, Belgium, China, Hungary, Turkey and United Kingdom.
  • Product Description
    cobas 4800 BRAF V600 Mutation Test for In Vitro Diagnostic Use Roche Molecular Systems, Inc., || Product Usage: || The primary use of the cobas 4800 BRAF V600 Mutation Test is the detection of the BRAF V600 mutations in DNA extracted from formalin-fixed, paraffin-embedded human melanoma tissue. It is intended to be used as an aid in selecting melanoma patients whose tumors carry BRAF V600 mutations for treatment with Zelboraf (vemurafenib).
  • Manufacturer
  • Model / Serial
    Device-associated diagnostic software
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    The COBAS 8000 data manager modular analyzer series (all versions) is a is a fully automated, random-access, software- controlled system for immunoassay and photometric analysis intended for qualitative and quantitative in-vitro determinations using a wide variety of tests.
  • Manufacturer
  • Model / Serial
    Device-associated diagnostic software
  • Product Classification
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
  • Manufacturer
913 more