FDA UDI
In Commercial Distribution
🇺🇸 United States
TruSeq Custom Amplicon Kit Dx - FFPE QC
DI: 00816270020064
·
Model: 20006259
·
ILLUMINA, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TruSeq Custom Amplicon Kit Dx - FFPE QC
- Primary DI
- 00816270020064
- Version / Model
- 20006259
- Catalog Number
- 20006259
- Company Name
- ILLUMINA, INC.
- Labeler DUNS
- 033305264
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-09
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 21c7b619-eb5c-4ba4-ab78-d3f09158e27e
Device Description
DNA from peripheral whole blood specimens and formalin-fixed, paraffin-embedded (FFPE) tissue. Using the reagents provided in the TruSeq Custom Amplicon Kit Dx, genomic DNA is processed through the library preparation steps, which specifically amplify the intended genomic regions of each sample using analyte specific oligonucleotides, while also adding the indexes and flow cell capture sequences to the amplified products. DNA from whole blood specimens follows the germline workflow, while DNA from FFPE tissue follows the somatic workflow. The resulting sample libraries are ready for sequencing on an Illumina high-throughput DNA sequence analyzer and analysis from instrument software modules that correspond to germline or somatic workflows.
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 | 00816270020064 | 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