Proper Name: cobas Babesia test for use on the cobas 6800/8800 Systems
Tradename: cobas Babesia
Manufacturer: Roche Molecular Systems, Inc.
- 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 or in pools comprised of aliquots of not more than six individual samples.
This test is not intended for use as an aid in diagnosis of Babesia infection.
This test is not intended for use on samples of cord blood.
This test is not intended for use on cadaveric blood specimens..
- May 6, 2020 Approval Letter - cobas Babesia
- August 29, 2019 Approval Letter - cobas Babesia
- August 27, 2019 Summary Basis for Regulatory Action - cobas Babesia