ANTI-TG ORG502

GUDID 04260157080010

ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) IN HUMAN SERUM OR PLASMA. THI

ORGENTEC Diagnostika GmbH

Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04260157080010
NIH Device Record Key21c13f7b-292b-4db4-8aa4-797e66289e8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameANTI-TG
Version Model NumberORG502
Catalog NumberORG502
Company DUNS328133103
Company NameORGENTEC Diagnostika GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+49061319258
EmailBARBARA.MANSI@ORGENTEC.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS104260157080010 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

Devices Manufactured by ORGENTEC Diagnostika GmbH

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04260157080010 - ANTI-TG2018-07-06 ANTI-TG IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST THYROGLOBULIN (TG) IN HUMAN
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04260157080034 - ENASCREEN2018-07-06 ENASCREEN IS AN ELISA TEST SYSTEM FOR THE QUALITATIVE SCREENING OF IgG CLASS AUTOANTIBODIES AGAINST EXTRACABLE NUCLEAR ANTIGENS
04260157080058 - ANTI-SS-A2018-07-06 ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-A (52 AND 60kDa) IN HU
04260157080065 - ANTI-SS-B2018-07-06 ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) IN HUMAN SERUM
04260157080072 - ANTI-SM2018-07-06 ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SM IN HUMAN SERUM OR PLASMA
04260157080089 - ANTI-RPN/SM2018-07-06 ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST RNP/SM IN HUMAN SERUM O
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