Qmedix 3144-18

GUDID 00850049545976

Qmedix T3 ELISA is intended for the quantitative determination of Triiodothyronine (T3) concentration in human serum.

Diagnostic Automation, Inc.

Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00850049545976
NIH Device Record Key1c18fa63-55b2-4fbe-a59c-c56625eb7f8d
Commercial Distribution StatusIn Commercial Distribution
Brand NameQmedix
Version Model NumberDACD3144-18
Catalog Number3144-18
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

Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.com
Phone8185913030
EmailOnestep@rapidtest.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
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
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
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
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850049545976 [Primary]

FDA Product Code

CDPRadioimmunoassay, Total Triiodothyronine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-21
Device Publish Date2023-06-13

On-Brand Devices [Qmedix]

00850054026033Qmedix Digoxin ELISA -The Quantitative Determination of Digoxin Concentration in Human Serum or
00850049545976Qmedix T3 ELISA is intended for the quantitative determination of Triiodothyronine (T3) concentr

Trademark Results [Qmedix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QMEDIX
QMEDIX
97272035 not registered Live/Pending
Diagnostic Automation, Inc.
2022-02-17

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