PreKnow

GUDID 00857275007070

PreKnow 5-Panel Instant Multi-Drug Screen Test Dip Card, THC-COC-OPI-AMP-PCP

IDUN SOLUTIONS LLC

Phencyclidine (PCP) IVD, kit, immunochromatographic test (ICT)

• Primary Device ID: 00857275007070
• NIH Device Record Key: 7815159c-862d-4e6c-b8c9-73bc2a76a3e1
• Commercial Distribution Discontinuation: 2018-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PreKnow
• Version Model Number: IDOA-756
• Company DUNS: 080651010
• Company Name: IDUN SOLUTIONS LLC
• 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: true
• 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	00857275007070 [Package]; Contains: 00857275007179; Package: [15 Units]; Discontinued: 2018-12-30; Not in Commercial Distribution
GS1	00857275007179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153050

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: 3
• Public Version Date: 2018-12-31
• Device Publish Date: 2018-05-22

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