Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) 300395

GUDID 08885013958171

The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. The kit is intended for in vitro diagnostic use.

VELA OPERATIONS SINGAPORE PTE. LTD.

Nucleic acid extraction/isolation kit IVD

• Primary Device ID: 08885013958171
• NIH Device Record Key: d5a0c636-1812-454a-a719-c164b653d216
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)
• Version Model Number: 300395
• Catalog Number: 300395
• 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	08885013958171 [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: 2020-05-21
• Device Publish Date: 2020-05-13

Devices Manufactured by VELA OPERATIONS SINGAPORE PTE. LTD.

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• 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