Qmedix 1669-15

GUDID 00850054026033

Qmedix Digoxin ELISA -The Quantitative Determination of Digoxin Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric.

Diagnostic Automation, Inc.

Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00850054026033
NIH Device Record Key29ac0b0f-080a-4b7a-b853-9580b01c54ed
Commercial Distribution StatusIn Commercial Distribution
Brand NameQmedix
Version Model NumberDACD1669-15
Catalog Number1669-15
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100850054026033 [Primary]

FDA Product Code

LCSRadioimmunoassay, Digoxin (125-I)

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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