PreKnow

GUDID 00857275007438

5 Multi Drug Test Panel (AMP 1000 • COC 300 • MET 1000 • OPI 2000 • THC 50)

IDUN SOLUTIONS LLC

Morphine/morphine metabolite IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00857275007438
• NIH Device Record Key: 046444c9-5ad6-4ff5-b031-5f646941878b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreKnow
• Version Model Number: 21115061010308-B
• 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: 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857275007438 [Package]; Contains: 00857275007537; Package: box [25 Units]; In Commercial Distribution
GS1	00857275007537 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-03
• Device Publish Date: 2018-08-02

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• 00857275007070: PreKnow 5-Panel Instant Multi-Drug Screen Test Dip Card, THC-COC-OPI-AMP-PCP