Sentosa ST Template Solutions (8) 300325

GUDID 08885013956337

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.

VELA OPERATIONS SINGAPORE PTE. LTD.

Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD Nucleic acid sequencing reagent kit IVD

• Primary Device ID: 08885013956337
• NIH Device Record Key: c93d0517-4eda-4899-b676-78a864f2f18a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentosa ST Template Solutions (8)
• Version Model Number: 300325
• Catalog Number: 300325
• Company DUNS: 595361724
• Company Name: VELA OPERATIONS SINGAPORE PTE. LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	08885013956337 [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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• 08885013953855 - ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96): 2022-03-07 ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid f
• 08885013958195 - ViroKey® HT Virus Total Nucleic Acid Kit (4x96): 2022-03-02 The ViroKey® HT Virus Total Nucleic Acid Kit (4x96) is used for magnetic beads-based nucleic acid extraction from virus in biol
• 08885013956313 - Sentosa ST Template Supplies (8): 2021-01-27 The Sentosa ST Template Kit is used to prepare enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonal ampl
• 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): 2021-01-27The 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.
• 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