PreKnow

GUDID 00857275007568

5 Multi Drug Test Panel ( AMP1000 • COC 300 • OPI2000 •THC 50 • PCP25)

IDUN SOLUTIONS LLC

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

• Primary Device ID: 00857275007568
• NIH Device Record Key: 3a450ebb-819c-4dc2-aaa8-11eb260ffd9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreKnow
• Version Model Number: 21505040010308-C
• 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	00857275007483 [Package]; Package: [25 Units]; In Commercial Distribution
GS1	00857275007568 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-03
• Device Publish Date: 2018-08-02

On-Brand Devices [PreKnow]

• 00857275007735: HCG Pregnancy Test Strip-3.5mm
• 00857275007568: 5 Multi Drug Test Panel ( AMP1000 • COC 300 • OPI2000 •THC 50 • PCP25)
• 00857275007445: LH Ovulation Test Strip-3.5mm
• 00857275007452: HCG Pregnancy Test Strip -3.5mm
• 00857275007438: 5 Multi Drug Test Panel (AMP 1000 • COC 300 • MET 1000 • OPI 2000 • THC 50)
• 00857275007391: 5 Multi Drug Test Panel (BZO 300 • COC 300 • MET 1000 • MOP 300 • THC 50)
• 00857275007506: Marijuana THC Single Drug Test Dip Card
• 00857275007490: Cocaine COC Single Drug Test Dip Card
• 00857275007261: PreKnow Instant 10 Panel Multi-Drug Test DipCard (BAR-BUP-BZO-COC-MET-MTD-OPI-OXY-TCA-THC)
• 00857275007070: PreKnow 5-Panel Instant Multi-Drug Screen Test Dip Card, THC-COC-OPI-AMP-PCP