PreKnow

GUDID 00857275007261

PreKnow Instant 10 Panel Multi-Drug Test DipCard (BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-TCA-THC)

IDUN SOLUTIONS LLC

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

• Primary Device ID: 00857275007261
• NIH Device Record Key: fb495308-cfa1-4e49-b8b8-94110533883c
• Commercial Distribution Discontinuation: 2018-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: PreKnow
• Version Model Number: IDOA-3105
• 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	00857275007186 [Primary]
GS1	00857275007261 [Package]; Contains: 00857275007186; Package: Kit [20 Units]; Discontinued: 2018-12-30; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153050

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: 2018-12-31
• Device Publish Date: 2018-05-23

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