PGDx elio™ tissue complete B01103200

GUDID 00192721000770

PGDx elio™ tissue complete software

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 ID00192721000770
NIH Device Record Keyba8aa3c2-0086-4574-bad8-e8559811c7a4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePGDx elio™ tissue complete
Version Model NumberB01103200
Catalog NumberB01103200
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
GS100192721000770 [Primary]
GS100192721000770 [Primary]
GS100192721000770 [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

On-Brand Devices [PGDx elio™ tissue complete]

00192721001418PGDx elio™ tissue complete reagent kit
00192721000770PGDx elio™ tissue complete software

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