Easy@Home THC Single Drug Screen Test (10 tests kit) EDTH-114

GUDID 00850253007246

EASY HEALTHCARE CORPORATION

Cannabinoid IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00850253007246
• NIH Device Record Key: 385198a8-bf67-4b27-bef7-d9cc2827a935
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home THC Single Drug Screen Test (10 tests kit)
• Version Model Number: EDTH-114-10
• Catalog Number: EDTH-114
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 10
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850253007246 [Primary]
GS1	10850253007243 [Package]; Package: [90 Units]; In Commercial Distribution
GS1	30850253007247 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121557

FDA Product Code

• LDJ: Enzyme Immunoassay, Cannabinoids

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: 2018-07-06
• Device Publish Date: 2016-08-26

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