Areta Multi-Drug Test Cup (100 tests kit) ACDOA-6125B-100

GUDID 00855944007581

Areta 12 Panel Drug Test Cup (100 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 ID: 00855944007581
• NIH Device Record Key: ab0d7c1c-81ec-45d6-bad6-a7d95f80ab94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Areta Multi-Drug Test Cup (100 tests kit)
• Version Model Number: ACDOA-6125B
• Catalog Number: ACDOA-6125B-100
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855944007581 [Primary]
GS1	30855944007582 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-12
• Device Publish Date: 2018-07-01

On-Brand Devices [Areta Multi-Drug Test Cup (100 tests kit)]

• 00855944007611: Areta 14-Panel Drug Test Cup (100 Test Kit): AMP,BAR,BUP,BZO,COC,MAMP (MET),MDMA,MTD,OPI2000 (OP
• 00855944007581: Areta 12 Panel Drug Test Cup (100 tests kit): BUP,THC,COC,MOP,MET,OXY,AMP,BAR,BZO,MTD,MDMA,PCP
• 00855944007550: Areta 5 Panel Drug Test Cup (100 Test Kit) - THC,COC,OPI2000,BZO,AMP
• 00855944007529: Areta 6 Panel Drug Test Cup (100 Test Kit) - AMP, BZO, COC, MAMP (MET), OPI2000 (OPI), THC