FDA.reportPublic FDA data

Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)

Primary DI
08885013958157
Brand
Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)
Company
VELA OPERATIONS SINGAPORE PTE. LTD.
Model
300353
Catalog number
300353
Device description
The Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24) is used for magnetic beads-based nucleic acid extraction from virus in biological specimens. The kit is intended for in vitro diagnostic use.
Published
2020-05-13
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
JJHClinical Sample Concentrator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJHClinical Sample ConcentratorClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08885013958157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08885013958157088850139581578885013958157

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
595361724
Device count
1
Premarket exempt
true
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
08885013953664Sentosa SA201 HSV-1/2 PCR Test3002163002162018-04-16
08885013958188ViroKey™ SX Virus Total Nucleic Acid Kit3006773006772020-06-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06955792702875Nucleic Acid Extraction and Purification Kit 2.0Sansure Biotech Inc.JJH2026-03-25
06955792702882Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
06955792702899Nucleic Acid Extraction and Purification Kit 3.0Sansure Biotech Inc.JJH2026-03-25
04053228040576EZ2 Connect MDxQIAGEN GmbHJJH2026-03-03
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