ViroKey™ SX Virus Total Nucleic Acid Kit 300677

GUDID 08885013958188

The ViroKey™ SX Virus Total Nucleic Acid Kit is used for magnetic beads-based nucleic acid extraction from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples in conjunction with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 on the Sentosa® SX101 instrument.

VELA OPERATIONS SINGAPORE PTE. LTD.

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 08885013958188
• NIH Device Record Key: 8753ff28-1c60-4697-b69e-ba2ecc7f8356
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViroKey™ SX Virus Total Nucleic Acid Kit
• Version Model Number: 300677
• Catalog Number: 300677
• 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	08885013958188 [Primary]

FDA Product Code

• JJH: Clinical Sample Concentrator

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: 2020-07-07
• Device Publish Date: 2020-06-29

Devices Manufactured by VELA OPERATIONS SINGAPORE PTE. LTD.

• 08885013953817 - ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (8x48): 2022-03-07 ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (8x48) is a real-time RT-PCR test intended for the qualitative detection of nucleic acid f
• 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): 2021-01-27 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