Sentosa SA201 Real-Time PCR Instrument 400125

GUDID 08885013950021

The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplification and detection system. It measures nucleic acid signals from reverse transcribed RNA and converts the signals to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes.

VELA OPERATIONS SINGAPORE PTE. LTD.

Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated

• Primary Device ID: 08885013950021
• NIH Device Record Key: 2e1b24d1-953e-4dd3-b591-5eae392edbf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sentosa SA201 Real-Time PCR Instrument
• Version Model Number: 400125
• Catalog Number: 400125
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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	08885013950021 [Primary]

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification System

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

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