Easy@Home Multi-Drug Test Cup (25 tests kit)

GUDID 10850253007564

25 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10850253007564
NIH Device Record Key9cf4318f-c808-474c-8751-a3598e4f4bef
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Multi-Drug Test Cup (25 tests kit)
Version Model NumberECDOA-7124
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
GS100850253007567 [Primary]
GS110850253007564 [Package]
Contains: 00850253007567
Package: [4 Units]
In Commercial Distribution
GS130850253007568 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-11-12
Device Publish Date2016-09-15

On-Brand Devices [Easy@Home Multi-Drug Test Cup (25 tests kit)]

1085025300760125 tests kit;14-Panel T-Cup 3-AD; COC/THC/OPI/BZO/MET/TCA/OXY/BUP/BAR/MTD/AMP/MDMA/PCP/PPX)OX/SG
1085025300758825 tests kit;12 Panel-T cup; AMP/BAR/BZO/BUP/COC/MDMA/MET/MTD/MOP/OXY/THC/PCP
1085025300756425 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
1085025300754025 tests kit;5-Panel T-Cup;COC/THC/OPI/AMP/MET
1081003863135325 tests kit;12-Panel T-Cup;AMP/BAR/BZO/COC/MDMA/MET/MTD/OPI/OXY/TCA/THC/PCP
1081003863133925 tests kit;14-Panel T-Cup 3-AD; COC/THC/OPI/BZO/MET/TCA/OXY/BUP/BAR/MTD/AMP/MDMA/PCP/PPX)OX/SG

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