U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. cobas Babesia
  1. Vaccines, Blood & Biologics

cobas Babesia

STN: 125699
Proper Name: cobas® Babesia test for use on the cobas® 6800/8800 Systems
Tradename: cobas® Babesia
Manufacturer: Roche Molecular Systems, Inc.
Indications:

  • The cobas® Babesia test for use on the cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, and other living donors.
  • This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Whole blood samples from all donors may be screened as individual samples.

Product Information

Supporting Documents