FDA.reportPublic FDA data

PGDx elio™ plasma focus Dx

Primary DI
00192721001463
Brand
PGDx elio™ plasma focus Dx
Company
PERSONAL GENOME DIAGNOSTICS INC.
Model
A0310602
Catalog number
A0310602
Device description
PGDx elio™ plasma focus Dx reagent kit
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SBYHigh Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SBYHigh Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic AcidsPathology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN230046000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN230046000PGDx elio plasma focus DxPersonal Genome Diagnostics, Inc.2024-08-01SBY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192721001463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192721001463001927210014631927210014630192721001463

GMDN Terms#

Term, Definition table
TermDefinition
Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a nucleic acid technique (NAT). It is intended to be used to select treatment options, predict or monitor the response to cancer therapy and the risk of recurrence or metastasis, and/or for tumour profiling (e.g., cell-free DNA or circulating tumour DNA screening).

Regulatory Flags#

DUNS number
963427120
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
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
00192721001241PGDx elio™ diversiPhiA0840101A08401012020-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00192721001494PGDx elio™ plasma focus DxPERSONAL GENOME DIAGNOSTICS INC.SBY2026-05-07