DRI Thyroxine (T4)

GUDID 00884883004177

Microgenics Corporation

Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00884883004177
NIH Device Record Key77dda4a7-ebfc-49ff-81e8-d48a5a1e7e48
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Thyroxine (T4)
Version Model Number10013070
Company DUNS122153799
Company NameMicrogenics Corporation
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 Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100884883004177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine

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 Date2016-09-22

On-Brand Devices [DRI Thyroxine (T4)]

0088488300417710013070
008848830034460454

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