PGDx elio™ platform B0110900

GUDID 00192721000763

PERSONAL GENOME DIAGNOSTICS INC.

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT) Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Primary Device ID00192721000763
NIH Device Record Keybe2d8122-a070-4ea6-a60a-00ec72cfb394
Commercial Distribution StatusIn Commercial Distribution
Brand NamePGDx elio™ platform
Version Model NumberB0110900
Catalog NumberB0110900
Company DUNS963427120
Company NamePERSONAL GENOME DIAGNOSTICS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100192721000763 [Primary]
GS100192721000763 [Primary]
GS100192721000763 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PZMNext Generation Sequencing Based Tumor Profiling Test
PZMNext Generation Sequencing Based Tumor Profiling Test
PZMNext Generation Sequencing Based Tumor Profiling Test

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

Devices Manufactured by PERSONAL GENOME DIAGNOSTICS INC.

00192721000756 - PGDx elio™ server2020-05-19
00192721000763 - PGDx elio™ platform2020-05-19
00192721000763 - PGDx elio™ platform2020-05-19
00192721000770 - PGDx elio™ tissue complete2020-05-19 PGDx elio™ tissue complete software
00192721001241 - PGDx elio™ diversiPhi2020-05-19
00192721001418 - PGDx elio™ tissue complete2020-05-19 PGDx elio™ tissue complete reagent kit

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