Easy@Home 9 Panel Instant Urine Drug Test (5 test kit) EDOAP-295-5

GUDID 00855944007390

5 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID00855944007390
NIH Device Record Key5716fb43-75df-4c6a-95d0-d2016d14c5c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home 9 Panel Instant Urine Drug Test (5 test kit)
Version Model NumberEDOAP-295
Catalog NumberEDOAP-295-5
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count5
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
GS100855944007390 [Primary]
GS130855944007391 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-08-01
Device Publish Date2018-07-01

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