Easy@Home Multi-Drug Screen Test (2 tests kit) EDOAP-6125B-2

GUDID 10850253007939

2 tests kit;12-Panel Dip Card;BUP/THC/COC/MOP/MET/OXY/AMP/BAR/BZO/MTD/MDMA/PCP

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10850253007939
NIH Device Record Keye16bf2a0-6f80-4693-8275-23945ac6c748
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Multi-Drug Screen Test (2 tests kit)
Version Model NumberEDOAP-6125B
Catalog NumberEDOAP-6125B-2
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count2
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
GS100850253007932 [Primary]
GS110850253007939 [Package]
Contains: 00850253007932
Package: Carton [180 Units]
In Commercial Distribution
GS130850253007933 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-11-12
Device Publish Date2018-07-01

On-Brand Devices [Easy@Home Multi-Drug Screen Test (2 tests kit)]

108502530079392 tests kit;12-Panel Dip Card;BUP/THC/COC/MOP/MET/OXY/AMP/BAR/BZO/MTD/MDMA/PCP
108502530074722 tests kit;12-Panel Dip Card;AMP-COC/OXY-THC/OPI/MET/BZO/MDMA/MTD/BAR/PCP/PPX
108502530074102 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA
108502530073592 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC

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