Easy@Home Multi-Drug Screen Test (1 test kit) EDOAP-1124-1

GUDID 00810038633367

1 test kit;12-Panel Dip Card;AMP-COC/OXY-THC/OPI/MET/BZO/MDMA/MTD/BAR/PCP/PPX

EASY HEALTHCARE CORPORATION

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 00810038633367
• NIH Device Record Key: 253d3013-c634-481c-b3e7-144f28104dc3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Multi-Drug Screen Test (1 test kit)
• Version Model Number: EDOAP-1124
• Catalog Number: EDOAP-1124-1
• Company DUNS: 080278407
• Company Name: EASY HEALTHCARE CORPORATION
• Device Count: 1
• 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	00810038633367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202567

FDA Product Code

• LCM: Enzyme Immunoassay, Phencyclidine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2022-01-06

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