FDA.reportPublic FDA data

PGDx elio™ server

Primary DI
00192721000756
Brand
PGDx elio™ server
Company
PERSONAL GENOME DIAGNOSTICS INC.
Model
B-01-10800
Catalog number
B-01-10800
Published
2020-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
PZMNext Generation Sequencing Based Tumor Profiling Test

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZMNext Generation Sequencing Based Tumor Profiling TestPathology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192063000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192063000PGDx elio tissue completePersonal Genome Diagnostics2020-04-24PZM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192721000756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192721000756001927210007561927210007560192721000756

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, to predict or monitor the response to treatment and the risk of recurrence or metastasis, using a nucleic acid technique (NAT). It is intended to be used to select treatment options and/or monitor the response to cancer therapy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963427120
Device count
1
Kit
true
Serial number
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
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
00860013470982GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) GENESIS by GENESEEQ softwareGeneseeq Technology IncPZM2025-12-29
00860013470999GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)Geneseeq Technology IncPZM2025-12-29
00192721001449PGDx elio™ serverPERSONAL GENOME DIAGNOSTICS INC.PZM2020-11-17
00192721001456PGDx elio™ serverPERSONAL GENOME DIAGNOSTICS INC.PZM2020-11-17
00192721001432PGDx elio™ serverPERSONAL GENOME DIAGNOSTICS INC.PZM2020-07-08
00192721000763PGDx elio™ platformPERSONAL GENOME DIAGNOSTICS INC.PZM2020-05-11
00192721000770PGDx elio™ tissue completePERSONAL GENOME DIAGNOSTICS INC.PZM2020-05-11
00192721001418PGDx elio™ tissue completePERSONAL GENOME DIAGNOSTICS INC.PZM2020-05-11