Elecsys Anti-Tg 09004998160

GUDID 07613336203521

Roche Diagnostics GmbH

Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID07613336203521
NIH Device Record Key10a374a4-0137-469d-8105-fa032288fe41
Commercial Distribution StatusIn Commercial Distribution
Brand NameElecsys Anti-Tg
Version Model Number09004998160
Catalog Number09004998160
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
GS107613336203521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JZOSYSTEM, TEST, THYROID AUTOANTIBODY

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 Anti-Tg]

0761333620352109004998160
0761333617147909005021190

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