Elecsys Total -Tau CSF 08846634160

GUDID 07613336221761

Roche Diagnostics GmbH

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Primary Device ID07613336221761
NIH Device Record Keyd17353e3-7555-4d45-982d-53cf48e08902
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys Total -Tau CSF
Version Model Number08846634160
Catalog Number08846634160
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336221761 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QSEAlzheimer’s disease pathology assessment test

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-31
Device Publish Date2023-08-23

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