MiSeqDx Reagent Kit v3
Basic Information
- Brand Name
- MiSeqDx Reagent Kit v3
- Primary DI
- 00816270020071
- Version / Model
- 20012552
- Catalog Number
- 20012552
- Company Name
- ILLUMINA, INC.
- Labeler DUNS
- 033305264
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-06
- Public Version
- 4
- Public Version Date
- 2022-01-10
- Public Version Status
- Update
- Public Device Record Key
- 24b0b061-7263-4cdf-80ae-8785b2013b72
- Distribution End Date
- 2021-12-23
Device Description
The MiSeqDx Reagent Kit v3 uses libraries prepared from DNA where sample indexes and capture sequences are added to targets. Sample libraries are captured on a flow cell and sequenced on the instrument using sequencing by synthesis (SBS) chemistry. SBS chemistry uses a reversible-terminator method to detect single nucleotide bases as they are incorporated into growing DNA strands. The Illumina MiSeqDx Reagent Kit v3 is a single-use set of reagents and consumables for sequencing one run of one or more sample libraries on the MiSeqDx Instrument. The number of sample libraries depends on the multiplexing supported by the upstream library preparation method. The MiSeqDx Reagent Kit v3 is an IVD kit consisting of the individual boxes listed below which are all labeled with the same Device Identifier: 20011196, MiSeqDx Reagent Kit v3, 1/2; 20011197, iSeqDx Reagent Kit v3, 2/2
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 | 00816270020071 | 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