Easy@Home THC Single Drug Screen Test (5 tests kit) EDTH-114-5

GUDID 00855944007475

5 tests kit;THC Single Panel

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 00855944007475
• NIH Device Record Key: e09c8875-d58c-4ab7-968f-64f12e720f49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home THC Single Drug Screen Test (5 tests kit)
• Version Model Number: EDTH-114
• Catalog Number: EDTH-114-5
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 5
• 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	00855944007475 [Primary]
GS1	30855944007476 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-01
• Device Publish Date: 2018-07-01

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