Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples)
Basic Information
- Brand Name
- Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples)
- Primary DI
- 00816270020484
- Version / Model
- 20051355
- Catalog Number
- 20051355
- Company Name
- ILLUMINA, INC.
- Labeler DUNS
- 033305264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-20
- Public Version
- 1
- Public Version Date
- 2022-10-28
- Public Version Status
- New
- Public Device Record Key
- 0bd632fc-5a25-4145-8c1a-7f2bcc042d14
Device Description
The Illumina® DNA Prep with Enrichment Dx Kit is a set of reagents and consumables used to prepare sample libraries from peripheral whole blood and formalin-fixed, paraffin-embedded tissue. User-supplied probe panels are required for the preparation of libraries targeting specific genomic regions of interest. The generated sample libraries are intended for use on Illumina's sequencing systems. The Illumina® DNA Prep with Enrichment Dx Kit is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20050020, Illumina® Prep Dx Tagmentation Reagents 1; 20050021, Illumina® DNA Prep Dx Tagmentation Reagents 2; 20050022, Illumina® Prep Dx Tagmentation Reagents 3; 20050023, Illumina® DNA Prep Dx Enrichment Reagents 1; 20050024, Illumina® DNA Prep Dx Enrichment Reagents 2; and 20050039, Illumina® Unique Dual Index Dx Set B (96 Indexes).
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| PFT | Reagents For Molecular Diagnostic Test Systems | Clinical Chemistry | 862.3800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62173 | Nucleic acid sequencing reagent kit IVD | A collection of reagents and other associated materials intended to be used on-board a nucleic acid sequencing instrument for the genetic analysis of a clinical specimen. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs). It does not contain analyte-specific reagents and is not intended to be used for whole genome or complementary deoxyribonucleic acid (cDNA) library construction. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816270020484 | GS1 |
Customer Contacts
- Phone
- 800-809-4566
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – -15 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius