Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) (20 tests/kit) EDTH-114-20

GUDID 10810038632015

20 tests per kit;THC Single Panel

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 10810038632015
• NIH Device Record Key: f42ee9d4-3e81-4617-9921-39ff29d93952
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Single Drug Screen Test (Cannabinoids Urine Test) (20 tests/kit)
• Version Model Number: EDTH-114
• Catalog Number: EDTH-114-20
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 20
• 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	00810038632018 [Primary]
GS1	10810038632015 [Package]; Contains: 00810038632018; Package: Carton [36 Units]; In Commercial Distribution
GS1	30810038632019 [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: 2022-02-25
• Device Publish Date: 2022-02-17

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