STN:125808
Proper Name: cobas Malaria test for use on the cobas 6800/8800 Systems
Tradename: cobas Malaria
Manufacturer: Roche Molecular Systems

Indication:

• The cobas® Malaria test for use on the cobas® 6800/8800 Systems (cobas® Malaria) is a qualitative in vitro nucleic acid screening test for the direct detection of Plasmodium (P. falciparum, P. malariae, P. vivax, P. ovale and P. knowlesi) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, as well as other living donors. It is also intended for use in testing whole blood samples to screen organ and tissue donors when samples are obtained while the donor’s heart is still beating.
  
  Whole blood samples from all donors are screened as individual samples.
  
  The test is not intended for use as an aid in diagnosis of Plasmodium infection.
  This test is not intended for use on samples of cord blood.
  This test is not intended for use on cadaveric blood specimens.

Product Information

• Package Insert - Cobas Malaria
• Package Insert - Whole Blood Collection Tube

Supporting Documents

• March 19, 2024 Approval Letter - cobas Malaria
• March 18, 2024 Summary Basis for Regulatory Action - Cobas Malaria