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System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection

FDA product code PFS · Class 2 · Immunology

3
Registered devices
0
Adverse events
2
Recalls
1
510(k) clearances

Devices with this code

MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run) — ILLUMINA, INC.Local Run Manager CF Clinical Seq 2.0 Micro Analysis Module — ILLUMINA, INC.Local Run Manager CF Clinical Sequencing Analysis Module — ILLUMINA, INC.

Recent 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 s
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 t

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