FDA.reportPublic FDA data

PGDx elio™ diversiPhi

Primary DI
00192721001241
Brand
PGDx elio™ diversiPhi
Company
PERSONAL GENOME DIAGNOSTICS INC.
Model
A0840101
Catalog number
A0840101
Published
2020-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00192721001241PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192721001241001927210012411927210012410192721001241

GMDN Terms#

Term, Definition table
TermDefinition
Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassayA collection of reagents and other associated materials intended to be used for the quantitative measurement and therapeutic monitoring of the antineoplastic drug methotrexate in a clinical specimen, using a chemiluminescent immunoassay method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963427120
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192721001463PGDx elio™ plasma focus DxA0310602A03106022026-05-07
00192721001494PGDx elio™ plasma focus DxB01103102B011031022026-05-07
00192721001449PGDx elio™ serverB-01-30800B-01-308002020-11-17
00192721001456PGDx elio™ serverB-01-40800B-01-408002020-11-17
00192721001432PGDx elio™ serverB-01-20800B-01-208002020-07-08
00192721000756PGDx elio™ serverB-01-10800B-01-108002020-05-11
00192721000763PGDx elio™ platformB0110900B01109002020-05-11
00192721000770PGDx elio™ tissue completeB01103200B011032002020-05-11
00192721001418PGDx elio™ tissue completeA0320100A03201002020-05-11

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
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