Easy@Home Multi-Drug Screen Test (10 tests kit) EDOAP-654-10

GUDID 01085025300792

10 tests kit; 5-Panel Dip Card; THC/COC/OPI/BZO/MET

EASY HEALTHCARE CORPORATION

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

• Primary Device ID: 01085025300792
• NIH Device Record Key: 1eaf8d6a-6660-4b1f-940f-0d01b8d5cec5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy@Home Multi-Drug Screen Test (10 tests kit)
• Version Model Number: EDOAP-654
• Catalog Number: EDOAP-654-10
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850253007925 [Primary]
GS1	01085025300792 [Package]; Contains: 00850253007925; Package: Carton [60 Units]; In Commercial Distribution
GS1	30850253007926 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133968

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: 2018-11-12
• Device Publish Date: 2018-07-01

On-Brand Devices [Easy@Home Multi-Drug Screen Test (10 tests kit)]

• 10855944007458: 10 tests kit;5-Panel Dip Card; AMP/BZO/COC/OPI/THC
• 10855944007007: 10 tests kit; 6-Panel Dip Card; THC/COC/OPI/OXY/MET/BZO
• 10850253007953: 10 tests kit;10-Panel Dip Card; THC/COC/OPI/MET/AMP/OXY/BAR/BZO/MTD/PCP
• 01085025300792: 10 tests kit; 5-Panel Dip Card; THC/COC/OPI/BZO/MET
• 10850253007885: 10 tests kit; 4-Panel Dip Card; COC/THC/OPI/MET
• 10850253007496: 10 tests kit;12-Panel Dip Card;AMP-COC/OXY-THC/OPI/MET/BZO/MDMA/MTD/BAR/PCP/PPX
• 10850253007403: 10 tests kit;6-Panel Dip Card;THC/COC/OPI/AMP/MET/BZO
• 10850253007335: 10 tests kit;5-Panel Dip Card;THC/COC/OPI/AMP/MET
• 30810038631685: 10 tests kit;5-Panel Dip Card; AMP/BZO/COC/OPI/THC