FDA Device Intelligence
Home › ILLUMINA, INC. › MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)

MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)

ILLUMINA, INC. · Model 15036620 · UDI-DI 00816270020026

PFS Prescription
1
510(k) clearances
0
Adverse events
2
Recalls
1
Facilities

Description

The Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay consists of library preparation and sample indexing reagents, sequencing reagents and consumables, MiSeqDx instrument and data analysis software. MiSeqDx Cystic Fibrosis Clinical Sequencing Assay is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15035429 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1/5 15038248 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1A 15038249 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 1B 15035436 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 2/5 15035430 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3/5 15038250 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3A 15038251 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 3B 15036622 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 4/5 15036623 MiSeqDx Cystic Fibrosis Clinical Sequencing Assay 5/5

Recalls

DateFirmReason
2014-11-13Illumina IncIt was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. The software cannot repor
2014-11-06Illumina IncIllumina 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 instrumen

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.