Easy@Home 9 Panel Instant Urine Drug Test (25 test kit) EDOAP-295-25

GUDID 00855944007413

25 Pack Easy@Home 9 Panel Instant Urine Drug Test - AMP,BUP,BZO,COC,MOP,MTD,OXY,PPX,THC

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 00855944007413
• NIH Device Record Key: d6c9041e-3e36-4c15-8c1d-5a34cb6a8dbc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home 9 Panel Instant Urine Drug Test (25 test kit)
• Version Model Number: EDOAP-295
• Catalog Number: EDOAP-295-25
• 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	00855944007413 [Primary]
GS1	10855944007410 [Package]; Package: Carton [20 Units]; In Commercial Distribution
GS1	30855944007414 [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: 2018-08-01
• Device Publish Date: 2018-07-01

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