Illumina Inc

Serial No. M70130, M70189, M70108, M70165, M70166, M70175, M70172, M70103.

Hematology and Pathology Devices

2

No

US Distribution to the states of AZ, GA, CA, OH, and VA., and one Internationally to France.

Illumina MiSeqDx Universal Kit 1.0, PN 15039608 || The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents and consumables used in the processing of human genomic DNA samples derived from peripheral whole blood, and in the subsequent targeted sequencing of the resulting sample libraries. User-supplied analyte specific reagents are required for the preparation of libraries targeting specific genomic regions of interest. The MiSeqDx Universal Kit 1.0 is intended for use with the MiSeqDx instrument.

Instrument Serial No. M70106, M00533L, M70114. Lot No. Shipped: K103313, K103461, K103404, K103487.

Hematology and Pathology Devices

2

No

US: MD, NY Non-US: France

Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.

M70113 M70144 M70131 M70138 M70143 M70119 M70134 M70156 M70103 M70123 M70159 M70153 M70136 M70102 M70137 M70130 M00533L M70139 M70132 M70160 M70106 M70135 M70107 M70104 M70108 M70157 M70105 M70165 M70116 M70172 M70166 M70114 M70158 M70109 M70115

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - US (nationwide) and the countries of: France, Germany, Italy, Norway, UK and United Arab Emirates.

Illumina Worklist Manager (IWM) (software v1.0.15), a component of Illumina MiSeqDx Platform. || Product Usage: The Illumina MiSeqDx is a sequencing instrument that measures fluorescence signals of labeled nucleotides through the use of instrument specific reagents and flow cells (MiSeqDx Universal Kit 1.0), imaging hardware, and data analysis software. The MiSeqDx Platform is intended for targeted sequencing of human genomic DNA from peripheral whole blood samples.