Elecsys Tg II 08906564190

GUDID 07613336169582

Roche Diagnostics GmbH

Thyroglobulin IVD, kit, chemiluminescent immunoassay
Primary Device ID07613336169582
NIH Device Record Keyce6538aa-50ae-49e5-ac2d-67605ccc5edb
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys Tg II
Version Model Number08906564190
Catalog Number08906564190
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
GS107613336169582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MSWSystem, test, thyroglobulin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-08
Device Publish Date2023-10-31

On-Brand Devices [Elecsys Tg II]

0761333620356908906556160
0761333616958208906564190

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