Easy@Home Multi-Drug Screen Test (15 tests kit)

GUDID 10850253007328

15 tests kit ;5-Panel Dip Card;THC/COC/OPI/AMP/MET

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID10850253007328
NIH Device Record Key0256ece4-269e-4422-b188-e8279bdb921d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Multi-Drug Screen Test (15 tests kit)
Version Model NumberEDOAP-254
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100850253007321 [Primary]
GS110850253007328 [Package]
Contains: 00850253007321
Package: [45 Units]
In Commercial Distribution
GS130850253007322 [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 Number5
Public Version Date2018-11-12
Device Publish Date2016-09-15

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

0085025300797015 tests kit; 6-Panel Dip Card; THC/COC/OPI/AMP/MET/BZO
1085025300789215 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
1085025300750215 tests kit;12-Panel Dip Card;AMP-COC/OXY-THC/OPI/MET/BZO/MDMA/MTD/BAR/PCP/PPX
1085025300745815 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA
1085025300737315 tests kit;5-Panel Dip Card;AMP/BZO/COC/OPI/THC
1085025300732815 tests kit ;5-Panel Dip Card;THC/COC/OPI/AMP/MET

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