FDA.reportPublic FDA data

Sentosa SX101

Primary DI
08885013950007
Brand
Sentosa SX101
Company
VELA OPERATIONS SINGAPORE PTE. LTD.
Model
400089
Catalog number
400089
Device description
Sentosa SX101 is an automated pipetting instrument designed for contamination-free, precise and correct measuring and transferring of liquids.
Published
2021-01-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JQWStation, Pipetting And Diluting, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQWStation, Pipetting And Diluting, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885013950007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885013950007088850139500078885013950007

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sample preparation instrument IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
595361724
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08885013953817ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (8x48)3010682022-02-25
08885013953855ViroKey® SARS-CoV-2 RT-PCR Test v2.0 (4x96)3010852022-02-25
08885013958195ViroKey® HT Virus Total Nucleic Acid Kit (4x96)3010883010882022-02-22
08885013956313Sentosa ST Template Supplies (8)3003283003282021-01-19
08885013956320Sentosa ST Template Reagents (8)3003193003192021-01-19
08885013956337Sentosa ST Template Solutions (8)3003253003252021-01-19
08885013956344Sentosa ST Template Beads (8)3003223003222021-01-19
08885013956368Sentosa SQ Sequencing Supplies (8)3003063003062021-01-19
08885013956375Sentosa SQ Sequencing Reagents (8)3003133003132021-01-19
08885013956382Sentosa SQ Sequencing Solutions (8)3003163003162021-01-19
08885013956511Sentosa SX IA Reactions Kit (4)3007333007332021-01-19
08885013956528Sentosa SX IA Reagents Kit (8)3007343007342021-01-19
08885013956535Sentosa SX IA Solution Kit (8)3007353007352021-01-19
08885013956566Sentosa SQ HIV-1 Positive Control Kit (96)3007293007292021-01-19
08885013956597Sentosa SQ HIV-1 Positive Control Kit (8)3008003008002021-01-19
08885013956542Sentosa SQ HIV-1 Genotyping Reagents (4x24)3007313007312021-01-18
08885013956559Sentosa SQ Virus Testing Solutions (4x24)3007323007322021-01-18
08885013953664Sentosa SA201 HSV-1/2 PCR Test3002163002162018-04-16
08885013958188ViroKey™ SX Virus Total Nucleic Acid Kit3006773006772020-06-29
08885013950021Sentosa SA201 Real-Time PCR Instrument4001254001252020-05-13

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Primary DI, Brand, Company table
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