PGDx elio™ diversiPhi A0840101

GUDID 00192721001241

PERSONAL GENOME DIAGNOSTICS INC.

Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay Methotrexate therapeutic drug monitoring IVD, kit, chemiluminescent immunoassay
Primary Device ID00192721001241
NIH Device Record Key451b1812-a96e-4c5c-9bc2-9b02a56cbc9b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePGDx elio™ diversiPhi
Version Model NumberA0840101
Catalog NumberA0840101
Company DUNS963427120
Company NamePERSONAL GENOME DIAGNOSTICS INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100192721001241 [Primary]
GS100192721001241 [Primary]
GS100192721001241 [Primary]

FDA Product Code

PFTReagents For Molecular Diagnostic Test Systems
PFTReagents For Molecular Diagnostic Test Systems
PFTReagents For Molecular Diagnostic Test Systems

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

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