Areta Multi-Drug Test Cup (25 tests kit) ACDOA-1144-25

GUDID 10810038630646

Areta 14-Panel Drug Test Cup (25 Test Kit): AMP,BAR,BUP,BZO,COC,MAMP (MET),MDMA,MTD,OPI2000 (OPI),OXY,PCP,PPX,TCA,THC

EASY HEALTHCARE CORPORATION

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• Primary Device ID: 10810038630646
• NIH Device Record Key: 984d3181-39a2-4b94-b29c-836ac32b92f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Areta Multi-Drug Test Cup (25 tests kit)
• Version Model Number: ACDOA-1144
• Catalog Number: ACDOA-1144-25
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 25
• 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	00810038630649 [Primary]
GS1	10810038630646 [Package]; Contains: 00810038630649; Package: Carton [4 Units]; In Commercial Distribution
GS1	30810038630640 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-07
• Device Publish Date: 2020-06-29

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

• 10855944007212: Areta 14-Panel Drug Test Cup (25 Test Kit): AMP,BAR,BUP,BZO,COC,MAMP (MET),MDMA,MTD,OPI2000 (OP
• 10810038630646: Areta 14-Panel Drug Test Cup (25 Test Kit): AMP,BAR,BUP,BZO,COC,MAMP (MET),MDMA,MTD,OPI2000 (OP