Duns Number:033305264
Device Description: The Illumina MiSeqDx Cystic Fibrosis 139-Variant Assay consists of library preparation and 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 (20 Run) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 15035471 MiSeqDx Cystic Fibrosis 139 Variant Assay 1/515038252, MiSeqDx Cystic Fibrosis 139 Variant Assay 1A; 15038253, MiSeqDx Cystic Fibrosis 139 Variant Assay 1B; 15035478, MiSeqDx Cystic Fibrosis 139 Variant Assay 2/5; 15035472, MiSeqDx Cystic Fibrosis 139 Variant Assay 3/5; 15038254, MiSeqDx Cystic Fibrosis 139 Variant Assay 3A; 15038255, MiSeqDx Cystic Fibrosis 139 Variant Assay 3B; 15036624, MiSeqDx Cystic Fibrosis 139 Variant Assay 4/5; 15038119, MiSeqDx Cystic Fibrosis 139 Variant Assay 5/5.
Catalog Number
DX-102-1003
Brand Name
MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run)
Version/Model Number
15036577
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K124006
Product Code
-
Product Code Name
-
Public Device Record Key
a450e111-06f1-4c60-ace2-71cc57c8e1ea
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 14, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 18 |
2 | A medical device with a moderate to high risk that requires special controls. | 7 |
3 | A medical device with high risk that requires premarket approval | 1 |