Home GUDID 00192721001463 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 Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false Product Codes# Code, Name table Code Name SBY High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SBY High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids Pathology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00192721001463 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00192721001463 00192721001463 192721001463 0192721001463
GMDN Terms# Term, Definition table Term Definition 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 in one or more of the following: select treatment options; predict or monitor the response to cancer therapy; risk assessment of cancer development, 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 DM exempt false Premarket exempt false HCT/P false Kit true Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00192721001494 PGDx elio™ plasma focus Dx B01103102 B01103102 2026-05-07 00192721001449 PGDx elio™ server B-01-30800 B-01-30800 2020-11-17 00192721001456 PGDx elio™ server B-01-40800 B-01-40800 2020-11-17 00192721001432 PGDx elio™ server B-01-20800 B-01-20800 2020-07-08 00192721000756 PGDx elio™ server B-01-10800 B-01-10800 2020-05-11 00192721000763 PGDx elio™ platform B0110900 B0110900 2020-05-11 00192721000770 PGDx elio™ tissue complete B01103200 B01103200 2020-05-11 00192721001418 PGDx elio™ tissue complete A0320100 A0320100 2020-05-11 00192721001241 PGDx elio™ diversiPhi A0840101 A0840101 2020-05-11
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00192721001494 PGDx elio™ plasma focus Dx PERSONAL GENOME DIAGNOSTICS INC. SBY 2026-05-07