MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run)
Basic Information
- Brand Name
- MiSeqDx Cystic Fibrosis 139 Variant Assay (20 Run)
- Primary DI
- 00816270020033
- Version / Model
- 15036577
- Catalog Number
- DX-102-1003
- Company Name
- ILLUMINA, INC.
- Labeler DUNS
- 033305264
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-14
- Public Version
- 4
- Public Version Date
- 2023-01-31
- Public Version Status
- Update
- Public Device Record Key
- a450e111-06f1-4c60-ace2-71cc57c8e1ea
- Distribution End Date
- 2023-01-30
Device 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 (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 1/5 15038252, 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59365 | Cystic fibrosis IVD, kit, multiplex | A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict one or multiple mutations associated with the inborn genetic disorder cystic fibrosis due to mutation in the cystic fibrosis conductance regulator (CFTR) gene, using a multiplex method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816270020033 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K124006 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius