FDA.reportPublic FDA data

Sentosa SQ Sequencing Supplies (8)

Primary DI
08885013956368
Brand
Sentosa SQ Sequencing Supplies (8)
Company
VELA OPERATIONS SINGAPORE PTE. LTD.
Model
300306
Catalog number
300306
Device description
The Sentosa SQ Sequencing Kit is used to perform up to 200 base-read sequencing of enriched, template-positive Ion Sphere™ Particles (ISPs) containing clonally amplified DNA. The Sentosa SQ Sequencing Kit is comprised of three components; Sentosa SQ Sequencing Supplies, Sentosa SQ Sequencing Solutions and Sentosa SQ Sequencing Reagents.
Published
2021-01-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
PFTReagents For Molecular Diagnostic Test Systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFTReagents For Molecular Diagnostic Test SystemsClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885013956368PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885013956368088850139563688885013956368

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid sequencing reagent kit IVDA collection of reagents and other associated materials intended to be used on-board a nucleic acid sequencing instrument for the genetic analysis of a clinical specimen. It typically consists of buffers, primers, enzymes (e.g., DNA polymerase, DNA ligase) and deoxynucleotides (dNTPs). It does not contain analyte-specific reagents and is not intended to be used for whole genome or complementary deoxyribonucleic acid (cDNA) library construction.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
595361724
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08885013950007Sentosa SX1014000894000892021-01-18
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816270020330DRAGEN™ for Illumina DNA Prep with Enrichment Dx Application for NextSeq 550DxILLUMINA, INC.PFT2026-04-27
04250306300212InviTrap Spin Universal RNA Kit (50)Invitek Molecular GmbHPFT2025-01-20
04250306300229InviTrap Spin Universal RNA Kit (250)Invitek Molecular GmbHPFT2025-01-20
04250306300410PSP Spin Stool DNA Basic Kit (50)Invitek Molecular GmbHPFT2025-01-20
04250306300427PSP Spin Stool DNA Basic Kit (250)Invitek Molecular GmbHPFT2025-01-20
04250306300922PSP SalivaGene DNA Kit (250)Invitek Molecular GmbHPFT2025-01-20
10190302018241MagMAX™ Viral/Pathogen II Nucleic Acid Isolation KitTHERMO FISHER SCIENTIFIC BALTICS UABPFT2023-03-22
00816270020392Local Run Manager DNA GenerateFASTQ Dx Module for MiSeq™DxILLUMINA, INC.PFT2022-11-07
00816270020415Local Run Manager DNA GenerateFASTQ Dx Module for NextSeq™ 550DxILLUMINA, INC.PFT2022-11-07
00816270020743DRAGEN™ for Illumina® DNA Prep with Enrichment Dx for NovaSeq™ 6000DxILLUMINA, INC.PFT2022-11-07
10190302015769MagMAX™ MVP II BINDING BEADSTHERMO FISHER SCIENTIFIC BALTICS UABPFT2022-10-26
10190302015776MagMAX™ Viral/Pathogen Binding SolutionTHERMO FISHER SCIENTIFIC BALTICS UABPFT2022-10-26
10190302015783MagMAX™ Viral/Pathogen Wash SolutionTHERMO FISHER SCIENTIFIC BALTICS UABPFT2022-10-26
10190302015790MagMAX™ Viral/Pathogen Proteinase KTHERMO FISHER SCIENTIFIC BALTICS UABPFT2022-10-26
10190302015806MagMAX™ Viral/Pathogen Elution BufferTHERMO FISHER SCIENTIFIC BALTICS UABPFT2022-10-26
00816270020453Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (96 samples)ILLUMINA, INC.PFT2022-10-20
00816270020460Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (96 samples)ILLUMINA, INC.PFT2022-10-20
00816270020477Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set A (16 samples)ILLUMINA, INC.PFT2022-10-20
00816270020484Illumina® DNA Prep with Enrichment Dx with UDP Indexes Set B (16 samples)ILLUMINA, INC.PFT2022-10-20
00816270020538NovaSeq™ 6000Dx S2 Reagent v1.5 Kit (300 cycles)ILLUMINA, INC.PFT2022-10-18
00816270020545NovaSeq™ 6000Dx S2 Buffer CartridgeILLUMINA, INC.PFT2022-10-18
00816270020552NovaSeq™ 6000Dx Library TubeILLUMINA, INC.PFT2022-10-18
00816270020576NovaSeq™ 6000Dx S4 Buffer CartridgeILLUMINA, INC.PFT2022-10-18
00816270020583NovaSeq™ 6000Dx Library Tube, 24 packILLUMINA, INC.PFT2022-10-18
00816270020668MiSeq™Dx Reagent Kit v3 MicroILLUMINA, INC.PFT2022-05-20
08885013956313Sentosa ST Template Supplies (8)VELA OPERATIONS SINGAPORE PTE. LTD.PFT2021-01-19
08885013956320Sentosa ST Template Reagents (8)VELA OPERATIONS SINGAPORE PTE. LTD.PFT2021-01-19
08885013956337Sentosa ST Template Solutions (8)VELA OPERATIONS SINGAPORE PTE. LTD.PFT2021-01-19
08885013956344Sentosa ST Template Beads (8)VELA OPERATIONS SINGAPORE PTE. LTD.PFT2021-01-19
08885013956375Sentosa SQ Sequencing Reagents (8)VELA OPERATIONS SINGAPORE PTE. LTD.PFT2021-01-19