FDA.reportPublic FDA data

PSP Spin Stool DNA Basic Kit (250)

Primary DI
04250306300427
Brand
PSP Spin Stool DNA Basic Kit (250)
Company
Invitek Molecular GmbH
Model
250 prep
Catalog number
1038120300
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
04250306300427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250306300427042503063004274250306300427

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
04250306300922PSP SalivaGene DNA Kit (250)250 prep10352003002025-01-20
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
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
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