Easy@Home Multi-Drug Screen Test (25 tests kit) EDOAP-3104-25

GUDID 30810038631371

25 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 30810038631371
• NIH Device Record Key: ce4653b1-9314-40ac-a022-f15b06a71d97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Multi-Drug Screen Test (25 tests kit)
• Version Model Number: EDOAP-3104
• Catalog Number: EDOAP-3104-25
• 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	00810038631370 [Primary]
GS1	30810038631371 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

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: 2020-07-06
• Device Publish Date: 2020-06-26

On-Brand Devices [Easy@Home Multi-Drug Screen Test (25 tests kit)]

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• 30810038631371: 25 tests kit;10-Panel Dip Card;AMP/BAR/BZO/COC/MTD/OPI/MET/THC/PCP/MDMA
• 30810038631128: 25 tests kit;4-Panel Dip Card; COC/THC/OPI/MET