cobas Zika

STN: BL 125653
Proper Name: cobas Zika, Nucleic acid test for use on the cobas 6800/8800 systems
Tradename: cobas Zika
Manufacturer: Roche Molecular Systems, Inc
Indications:

• Qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in human plasma.

Product Information

• Package Insert - cobas Zika

Supporting Documents

• February 25, 2021 Approval Letter - Cobas Zika
• February 12, 2018 Approval Letter - Cobas Zika
• October 5, 2017 Approval Letter - cobasZika
• October 4, 2017 Summary Basis for Regulatory Action - cobas Zika
• Approval History, Letters, Reviews, and Related Documents - cobas Zika