FDA UDI
In Commercial Distribution
🇺🇸 United States
Sentosa SQ Sequencing Solutions (8)
DI: 08885013956382
·
Model: 300316
·
VELA OPERATIONS SINGAPORE PTE. LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sentosa SQ Sequencing Solutions (8)
- Primary DI
- 08885013956382
- Version / Model
- 300316
- Catalog Number
- 300316
- Company Name
- VELA OPERATIONS SINGAPORE PTE. LTD.
- Labeler DUNS
- 595361724
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-19
- Public Version
- 1
- Public Version Date
- 2021-01-27
- Public Version Status
- New
- Public Device Record Key
- 9d2f2a1f-7605-4da0-b113-e0c65ae962b3
Device Description
The Sentosa SQ Sequencing Kit is used to perform up to 200 base-read sequencing of enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonally amplified DNA. The Sentosa SQ Sequencing Kit is comprised of three components; Sentosa SQ Sequencing Supplies, Sentosa SQ Sequencing Solutions and Sentosa SQ Sequencing Reagents.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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 |
|---|---|---|---|---|
| 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 | 08885013956382 | GS1 |