PreciControl Total-Tau 07357028190

GUDID 07613336149881

Roche Diagnostics GmbH

Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control Tau protein IVD, control
Primary Device ID07613336149881
NIH Device Record Key81390893-051a-4ad9-86d9-c069b739569e
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreciControl Total-Tau
Version Model Number07357028190
Catalog Number07357028190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336149881 [Primary]

FDA Product Code

JJXSingle (specified) analyte controls (assayed and unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-21
Device Publish Date2023-08-11

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