FDA.reportPublic FDA data

Sentosa ST401e

Primary DI
08885013950076
Brand
Sentosa ST401e
Company
VELA OPERATIONS SINGAPORE PTE. LTD.
Model
400120
Catalog number
400120
Device description
ST401e is used for enrichment and forms part of SQ301 Platform.
Published
2016-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PFFHigh Throughput Dna Sequence Analyzer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PFFHigh Throughput Dna Sequence AnalyzerImmunology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885013950076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885013950076088850139500768885013950076

GMDN Terms#

Term, Definition table
TermDefinition
Clinical laboratory information systemA dedicated assembly of devices designed to electronically receive, collect, store, display, output and distribute clinical laboratory information (e.g., transfer of digital images), within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. Some systems will also assist in data management/analysis. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded, and not directly used to run, steer, or control laboratory analysers or equipment).

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10190302017794Ion Torrent™ Genexus™ Dx Integrated SequencerLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2025-10-13
10190302018883Ion Torrent Genexus Dx SoftwareLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2025-07-24
10190302019958Torrent Suite DX SW, Installer V5.14.2LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2025-02-19
10190302017848Torrent Suite DX SW, Installer V5.14LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2023-03-20
00816270020637NovaSeq™ 6000DxILLUMINA, INC.PFF2022-10-18
00816270020699MiSeq™ Dx (China)ILLUMINA, INC.PFF2022-04-25
10190302016810Torrent Suite DX, Installer v5.12.5LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2022-01-04
10190302014090Torrent Suite DX, Installer v5.8LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2019-03-27
00816270020125NextSeq 550Dx Sequencing SystemILLUMINA, INC.PFF2018-02-09
10190302005654Torrent Suite™ Dx SW, V5.6.4LIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2017-08-15
08885013950069Sentosa ST401iVELA OPERATIONS SINGAPORE PTE. LTD.PFF2017-03-28
08885013950045Sentosa SQ301 SequencerVELA OPERATIONS SINGAPORE PTE. LTD.PFF2016-09-22
00816270020002MiSeqDx InstrumentILLUMINA, INC.PFF2016-09-20
10190302000833Personal Genome Machine™ Dx (PGM™) DxLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01
10190302000840Ion PGM™ Dx Chip MinifugeLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01
10190302000857Ion One Touch™ DxLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01
10190302000864Ion One Touch™ ES DxLIFE TECHNOLOGIES HOLDINGS PTE. LTD.PFF2016-08-01