Qmedix 1669-15

GUDID 00850054026033

Digoxin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	00850054026033
NIH Device Record Key	29ac0b0f-080a-4b7a-b853-9580b01c54ed
Commercial Distribution Status	In Commercial Distribution
Brand Name	Qmedix
Version Model Number	DACD1669-15
Catalog Number	1669-15
Company DUNS	878252071
Company Name	Diagnostic Automation, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00850054026033 [Primary]

LCS	Radioimmunoassay, Digoxin (125-I)

Steralize Prior To Use	false
Device Is Sterile	false

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

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