Areta Multi-Drug Test Cup (25 tests kit) ACDOA-754-25

GUDID 10810038636990

Areta 5 Panel Drug Test Cup (25 Test Kit) - THC,COC,OPI2000,BZO,AMP

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID10810038636990
NIH Device Record Key8fe21820-e10d-402e-b194-a6734e301023
Commercial Distribution StatusIn Commercial Distribution
Brand NameAreta Multi-Drug Test Cup (25 tests kit)
Version Model NumberACDOA-754
Catalog NumberACDOA-754-25
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
GS100810038636993 [Primary]
GS110810038636990 [Package]
Contains: 00810038636993
Package: [4 Units]
In Commercial Distribution
GS130855944007278 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-08
Device Publish Date2024-09-30

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
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