Elecsys Phospho-Tau (181P) CSF 08846715190

GUDID 07613336167663

Roche Diagnostics GmbH

Tau protein IVD, kit, enzyme immunoassay (EIA)
Primary Device ID07613336167663
NIH Device Record Keyf48155f8-d996-47aa-b9bd-0875bc47784c
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys Phospho-Tau (181P) CSF
Version Model Number08846715190
Catalog Number08846715190
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
GS107613336167663 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-13
Device Publish Date2022-12-17

On-Brand Devices [Elecsys Phospho-Tau (181P) CSF]

0761333620836608846693160
0761333616766308846715190

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