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 Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automated
Primary Device ID08885013950021
NIH Device Record Key2e1b24d1-953e-4dd3-b591-5eae392edbf3
Commercial Distribution StatusIn Commercial Distribution
Brand NameSentosa SA201 Real-Time PCR Instrument
Version Model Number400125
Catalog Number400125
Company DUNS595361724
Company NameVELA OPERATIONS SINGAPORE PTE. LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108885013950021 [Primary]
GS108885013950021 [Primary]
GS108885013950021 [Primary]

FDA Product Code

OOIReal Time Nucleic Acid Amplification System
OOIReal Time Nucleic Acid Amplification System
OOIReal Time Nucleic Acid Amplification System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-21
Device Publish Date2020-05-13

Devices Manufactured by VELA OPERATIONS SINGAPORE PTE. LTD.

08885013950021 - Sentosa SA201 Real-Time PCR Instrument2020-05-21The 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.
08885013950021 - Sentosa SA201 Real-Time PCR Instrument2020-05-21 The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplification and detection system. It measures nucleic a
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08885013958157 - Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)2020-05-21 The Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) is used for magnetic beads-based nucleic acid extraction from virus in b
08885013958171 - Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)2020-05-21 The Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24) is used for magnetic beads-based nucleic acid extraction from virus in b

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