Easy@Home TRA Single Drug Screen Test (25 tests kit)

GUDID 10850253007915

EASY HEALTHCARE CORPORATION

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10850253007915
NIH Device Record Keyf3171ead-e325-481d-836b-6558173773f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home TRA Single Drug Screen Test (25 tests kit)
Version Model NumberEDTR-114
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count25
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-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850253007918 [Primary]
GS110850253007915 [Package]
Contains: 00850253007918
Package: Carton [40 Units]
In Commercial Distribution
GS130850253007919 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LDJEnzyme Immunoassay, Cannabinoids

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-20

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