Sentosa SX IA Solution Kit (8) 300735

GUDID 08885013956535

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.

VELA OPERATIONS SINGAPORE PTE. LTD.

Nucleic acid sequencing reagent kit IVD

• Primary Device ID: 08885013956535
• NIH Device Record Key: 05788ff7-c6aa-45ff-a057-78eee2681949
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentosa SX IA Solution Kit (8)
• Version Model Number: 300735
• Catalog Number: 300735
• Company DUNS: 595361724
• Company Name: VELA OPERATIONS SINGAPORE PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08885013956535 [Primary]

FDA Product Code

• PFT: Reagents For Molecular Diagnostic Test Systems

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-27
• Device Publish Date: 2021-01-19

Devices Manufactured by VELA OPERATIONS SINGAPORE PTE. LTD.

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• 08885013956320 - Sentosa ST Template Reagents (8): 2021-01-27 The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal ampl
• 08885013956337 - Sentosa ST Template Solutions (8): 2021-01-27 The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal ampl
• 08885013956344 - Sentosa ST Template Beads (8): 2021-01-27 The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal ampl
• 08885013956368 - Sentosa SQ Sequencing Supplies (8): 2021-01-27 The Sentosa SQ Sequencing Kit is used to perform up to 200 base-read sequencing of enriched, template-positive Ion Sphere™ Par