Devices

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
    Immunology and Microbiology Devices
  • 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
    Roche Molecular Systems, Inc.
  • 1 Event

Manufacturer

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

918 devices with a similar name

Learn more about the data here

CREATININE REAGENTS COBAS MIRA, ALL LOTS
SAMPLE CONTAINERS COBAS INTEGRA, LOT NO.000407
Analyzers, laboratory, biochemistry, automated, Cobas Integra model 400. catalog number: 1045199
Cobas b 123 Fluid Pack 200 and Cobas b 123 Fluid Pack 400, Registration No. 10287410927; Cobas b ...
cobas b 123 Sensor Cartridge BG / ISE / GLU / LAC, an integral part of the COBAS B 123 POC System...
913 more