Identity
- Trade Name
- Sentosa ST Template Reagents (8) FDA UDI
- Generic Name
- Nucleic acid sequencing reagent kit IVD FDA UDI
- Device Name
- The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal amplified DNA for up to 200 base-read sequencing of a library. Sentosa ST Template Kit is comprised of four components; Sentosa ST Template Supplies, Sentosa ST Template Solutions, Sentosa ST Template Reagents and Sentosa ST Template Beads. FDA UDI
- Model / Reference
- 300319 FDA UDI
- Description
- The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal amplified DNA for up to 200 base-read sequencing of a library. Sentosa ST Template Kit is comprised of four components; Sentosa ST Template Supplies, Sentosa ST Template Solutions, Sentosa ST Template Reagents and Sentosa ST Template Beads. FDA UDI
Identifiers
- Catalog Number
- 300319 FDA UDI
- Primary DI / UDI-DI
- 08885013956320 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 ST Template Reagents (8) by Vela Operations Singapore Pte. Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Nucleic acid sequencing reagent kit IVD.
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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 50f64752-363d-400f-8e4b-267659a3ba5e 34 fields · synced Jun 8, 2026