MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)
Basic Information
- Brand Name
- MiSeqDx Cystic Fibrosis Clinical Sequencing Assay (6 Run)
- Primary DI
- 00816270020026
- Version / Model
- 15036620
- Catalog Number
- DX-102-1001
- Company Name
- ILLUMINA, INC.
- Labeler DUNS
- 033305264
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2023-01-31
- Public Version Status
- Update
- Public Device Record Key
- 0e2913bc-ca16-413e-aefa-e6d935e4dd34
- Distribution End Date
- 2023-01-30
Device 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
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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PFS | System, Cystic Fibrosis Transmembrane Conductance Regulator Gene, Variant Gene Sequence Detection | Immunology | 866.5900 | 2 |
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 | 00816270020026 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132750 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius