Sentosa SQ 318 Chip Kit (8) 300300

GUDID 08885013956399

The Sentosa SQ 318 Chip Kit is used to perform up to 200 base-read sequencing of enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonally amplified DNA.

VELA OPERATIONS SINGAPORE PTE. LTD.

Nucleic acid sequencing reagent kit IVD

• Primary Device ID: 08885013956399
• NIH Device Record Key: e6177b87-6e2f-4ed6-84b7-070e3c835295
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentosa SQ 318 Chip Kit (8)
• Version Model Number: 300300
• Catalog Number: 300300
• 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: true
• Expiration Date: false
• 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	08885013956399 [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: 2020-05-21
• Device Publish Date: 2020-05-13

Devices Manufactured by VELA OPERATIONS SINGAPORE PTE. LTD.

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