FDA.reportPublic FDA data

Sentosa SA201 HSV-1/2 PCR Test

Primary DI
08885013953664
Brand
Sentosa SA201 HSV-1/2 PCR Test
Company
VELA OPERATIONS SINGAPORE PTE. LTD.
Model
300216
Catalog number
300216
Device description
Sentosa SA201 HSV-1/2 PCR Test is a real-time PCR based in vitro diagnostic test to detect and differentiate HSV1 and HSV2 virus DNA qualitatively.
Published
2018-04-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
OQOHerpes Simplex Virus Nucleic Acid Amplification Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQOHerpes Simplex Virus Nucleic Acid Amplification AssayMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885013953664PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885013953664088850139536648885013953664

GMDN Terms#

Term, Definition table
TermDefinition
Thermal cycler nucleic acid amplification analyser IVD, laboratory, semi-automatedAn electrically-powered laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or identified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen prior to amplification, and generally operates with reduced technician involvement and automation of some, but not all procedural steps.

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
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
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
25420045510187Aptima®Hologic, Inc.OQO2018-01-16
15420045507210Aptima®Hologic, Inc.OQO2017-06-23
15420045507227Aptima®Hologic, Inc.OQO2017-06-23
15420045507234Aptima®Hologic, Inc.OQO2017-06-23
25420045507248Aptima®Hologic, Inc.OQO2017-02-16
04053228004660artus® HSV-1/2 QS-RGQ MDx KitQIAGEN GmbHOQO2017-01-04
00875197004434cobas® 4800 System Lysis KitRoche Molecular Systems, Inc.OQO2016-09-24
00875197004458cobas® 4800 Systems Internal Control KitRoche Molecular Systems, Inc.OQO2016-09-24
00875197005264cobas® 4800 System Lysis KitRoche Molecular Systems, Inc.OQO2016-09-24
20816101025507Simplexa™ HSV 1 & 2 DirectDIASORIN MOLECULAR LLCOQO2016-09-22
20816101025514Simplexa™ HSV 1 & 2 Positive Control PackDIASORIN MOLECULAR LLCOQO2016-09-22
30014613312109AmpliVueQUIDEL CORPORATIONOQO2016-09-15
00840487101032Mutlicode®-RTx HSV 1&2 KitLUMINEX CORPORATIONOQO2016-09-09
00382904417482Control Set for the BD ProbeTec™ Herpes Simplex VirusesBECTON, DICKINSON AND COMPANYOQO2016-07-07
00382904417499BD ProbeTec™ Herpes Simplex Viruses Assays Reagent PackBECTON, DICKINSON AND COMPANYOQO2016-07-07