FDA-Device2014-12-31Class III
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Illumina Inc
Hazard
Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on the MiSeqDx instrument.
Sold states
US: MD, NY Non-US: France
Affected count
19 units
Manufactured in
5200 Illumina Way, San Diego, CA, United States
Products
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0850-2015Don't want to check this manually?
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