Easy@Home THC Single Drug Screen Test (15 tests kit) EDTH-114

GUDID 00850253007253

EASY HEALTHCARE CORPORATION

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Primary Device ID00850253007253
NIH Device Record Key6f680a26-954e-48b8-a6ed-f94e0c019a65
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home THC Single Drug Screen Test (15 tests kit)
Version Model NumberEDTH-114-15
Catalog NumberEDTH-114
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count15
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850253007253 [Primary]
GS110850253007250 [Package]
Package: [60 Units]
In Commercial Distribution
GS130850253007254 [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 Date2016-08-26

On-Brand Devices [Easy@Home THC Single Drug Screen Test (15 tests kit)]

00850253007253EDTH-114-15
30810038630152EDTH-114
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