AccuDiag ™ 3149-18

GUDID 00894175000893

AccuDiag ™ T4 ELISA Kit For the quantitative determination of the Total Thyroxine (T4) concentration in human serum.

Diagnostic Automation, Inc.

Total thyroxine (TT4) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00894175000893
NIH Device Record Keyda176cf4-7cac-487f-b240-5ccf0c846403
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuDiag ™
Version Model NumberDACD3149-18
Catalog Number3149-18
Company DUNS878252071
Company NameDiagnostic Automation, Inc.
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com
Phone818-591-3030
EmailOnestep@rapidtest.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit
Storage Environment TemperatureBetween 2 Degrees Fahrenheit and 8 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100894175000893 [Primary]

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 Date2023-06-22
Device Publish Date2023-06-14

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Trademark Results [AccuDiag]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACCUDIAG
ACCUDIAG
85042566 4091726 Live/Registered
Diagnostic Automation, Inc.
2010-05-19

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