NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles)
Basic Information
- Brand Name
- NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles)
- Primary DI
- 00816270020132
- Version / Model
- 20028870
- Catalog Number
- 20028870
- Company Name
- ILLUMINA, INC.
- Labeler DUNS
- 033305264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-15
- Public Version
- 2
- Public Version Date
- 2021-07-30
- Public Version Status
- Update
- Public Device Record Key
- cd57fb4b-787d-479b-924c-e48450391f47
Device Description
The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 Cycles) is a set of reagents and consumables intended for sequencing of sample libraries when used with validated assays. The kit is intended for use with the NextSeq 550Dx instrument and analytical software. The NextSeq™ 550Dx High Output Reagent Kit v2.5 (75 cycles) is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20028870, NextSeq™ 550Dx High Output Reagent Kit v2.5, 75 cycles; 20019560, NextSeq™ 550Dx High Output Reagent Cartridge v2, 75 cycles; 20019561, NextSeq™ 550Dx Buffer Cartridge v2, 75 cycles; 20031098, NextSeqTM 550Dx High Output Flow Cell Cartridge v2.5, 75 cycles; 20019563, NextSeq™ 550Dx Accessory Box – 75 cycles.
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
- 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 | 00816270020132 | GS1 |
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
- -25 – -15 Degrees Celsius