Areta Multi-Drug Test Cup (25 tests kit) ACDOA-6125B-25

GUDID 10855944007298

Areta 12 Panel Drug Test Cup (25 tests kit): 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 ID10855944007298
NIH Device Record Keyc7f34287-8b6c-4914-a8e5-50f0a2815c28
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreta Multi-Drug Test Cup (25 tests kit)
Version Model NumberACDOA-6125B
Catalog NumberACDOA-6125B-25
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
GS100855944007291 [Primary]
GS110855944007298 [Package]
Contains: 00855944007291
Package: Carton [4 Units]
In Commercial Distribution
GS130855944007292 [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 Number3
Public Version Date2018-11-12
Device Publish Date2018-07-01

On-Brand Devices [Areta Multi-Drug Test Cup (25 tests kit)]

00855944007505Areta 6 Panel Drug Test Cup (25 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC
10855944007298Areta 12 Panel Drug Test Cup (25 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
10855944007274Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP
10810038636990Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.