Total Thyroxine (T4) ELISA EIA-1781

GUDID 04048474017816

For the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders.

DRG Instruments Gesellschaft mit beschränkter Haftung

Multiple thyroid marker IVD, kit, enzyme immunoassay (EIA)
Primary Device ID04048474017816
NIH Device Record Keyb7ce936c-283a-4c21-a6fe-f6617c07cc81
Commercial Distribution StatusIn Commercial Distribution
Brand NameTotal Thyroxine (T4) ELISA
Version Model NumberEIA-1781
Catalog NumberEIA-1781
Company DUNS317134468
Company NameDRG Instruments Gesellschaft mit beschränkter Haftung
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

Phone1 973-564-7555
Emailcorpoffice@drg-international.com
Phone1 973-564-7555
Emailcorpoffice@drg-international.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

Device Identifiers

Device Issuing AgencyDevice ID
GS104048474017816 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-04
Device Publish Date2023-08-26

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