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