Identity
- Trade Name
- Sentosa SX IA Solution Kit (8) FDA UDI
- Generic Name
- Nucleic acid sequencing reagent kit IVD FDA UDI
- Device Name
- The Sentosa SX IA Template Prep Kit is intended for isothermal template preparation after library preparation is complete. it is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonally amplified DNA for up to 200 base-read sequencing of a library. The Sentosa SX IA Template Prep Kit is comprised of three components; the Sentosa SX IA Reactions Kit, the Sentosa SX IA Reagents Kit and the Sentosa SX IA Solutions Kit. FDA UDI
- Model / Reference
- 300735 FDA UDI
- Description
- The Sentosa SX IA Template Prep Kit is intended for isothermal template preparation after library preparation is complete. it is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonally amplified DNA for up to 200 base-read sequencing of a library. The Sentosa SX IA Template Prep Kit is comprised of three components; the Sentosa SX IA Reactions Kit, the Sentosa SX IA Reagents Kit and the Sentosa SX IA Solutions Kit. FDA UDI
Identifiers
- Catalog Number
- 300735 FDA UDI
- Primary DI / UDI-DI
- 08885013956535 FDA UDI
- FDA Product Code
- PFT FDA UDI
- GMDN Term
- Nucleic acid sequencing reagent kit IVD FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.3800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nucleic acid sequencing reagent kit IVD
Sentosa SX IA Solution Kit (8) by Vela Operations Singapore Pte. Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Vela Operations Singapore Pte. Ltd.
Sources (1)
- FDA UDI 05788ff7-c6aa-45ff-a057-78eee2681949 34 fields · synced May 30, 2026