FDA.reportPublic FDA data

PSP SalivaGene DNA Kit (250)

Primary DI
04250306300922
Brand
PSP SalivaGene DNA Kit (250)
Company
Invitek Molecular GmbH
Model
250 prep
Catalog number
1035200300
Published
2025-01-20
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
04250306300922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250306300922042503063009224250306300922

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
331869789
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
04250306300724InviMag Universal Kit /KF96InviMag74503002002025-04-01
04250306300823InviMag Universal Kit /KF96 w/o plasticInviMag74503002502025-04-01
04250306301219SalivaGene CollectorSalivaGene10352112002025-02-12
04250306300212InviTrap Spin Universal RNA Kit (50)50 prep10601002002025-01-20
04250306300229InviTrap Spin Universal RNA Kit (250)250 prep10601003002025-01-20
04250306300311RTP Pathogen Kit (50)50 prep10405002002025-01-20
04250306300328RTP Pathogen Kit (250)250 prep10405003002025-01-20
04250306300410PSP Spin Stool DNA Basic Kit (50)50 prep10381202002025-01-20
04250306300427PSP Spin Stool DNA Basic Kit (250)250 prep10381203002025-01-20
04250306301110SalivaGene Swab ComfortSalivaGene10352311002024-11-20
04250306300915PSP SalivaGene DNA Kit 50 prep10352002002024-09-02

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
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
08885013956368Sentosa SQ Sequencing Supplies (8)VELA OPERATIONS SINGAPORE PTE. LTD.PFT2021-01-19
08885013956375Sentosa SQ Sequencing Reagents (8)VELA OPERATIONS SINGAPORE PTE. LTD.PFT2021-01-19