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MiSeqDx CF 139 Variant Assay (2 Run)

ILLUMINA, INC. · Model 15036580 · UDI-DI 00816270020019

PFR Prescription
1
510(k) clearances
0
Adverse events
0
Recalls
1
Facilities

Description

The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis 139 Variant Assay (2 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15041293 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/5 15041291 MiSeqDx Cystic Fibrosis 139 Variant Assay 1A 15041292 MiSeqDx Cystic Fibrosis 139 Variant Assay 1B 15041294 MiSeqDx Cystic Fibrosis 139 Variant Assay 2/5 15041297 MiSeqDx Cystic Fibrosis 139 Variant Assay 3/5 15041295 MiSeqDx Cystic Fibrosis 139 Variant Assay 3A 15041296 MiSeqDx Cystic Fibrosis 139 Variant Assay 3B 15041298 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 4/5 15041299 MiSeqDx Cystic Fibrosis 139 Variant Assay Box 5/5

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.