ADVIA Centaur Anti-Thyroglobulin II (aTgII) 11201760

GUDID 00630414245362

ADVIA Centaur Anti-Thyroglobulin II (aTgII) - 500T

SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay
Primary Device ID00630414245362
NIH Device Record Key2dec7171-b4c6-4f04-b56f-e2e765eb3fc4
Commercial Distribution StatusIn Commercial Distribution
Brand NameADVIA Centaur Anti-Thyroglobulin II (aTgII)
Version Model Number11201760
Catalog Number11201760
Company DUNS296822794
Company NameSIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM
Phone+1(877)229-3711
EmailCONTACT@SIEMENS-HEALTHINEERS.COM

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100630414245362 [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 Date2026-02-12
Device Publish Date2026-02-04

On-Brand Devices [ADVIA Centaur Anti-Thyroglobulin II (aTgII)]

00630414245362ADVIA Centaur Anti-Thyroglobulin II (aTgII) - 500T
00630414245355ADVIA Centaur Anti-Thyroglobulin II (aTgII) - 100T

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