Panels › Immunology › Product code PFS · Class 2
System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection
Regulation 866.5900
0510(k)s in 12 months (1 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PFS
| Company | 510(k)s | Recalls |
|---|---|---|
| Illumina, Inc. | 1 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2014 | Illumina Inc 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 Terminated |
PFS | K132750 |
| Dec 23, 2014 | Illumina Inc Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform. Terminated |
PFS | K132750 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.