PreChek

GUDID 00857275007117

12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300• BZO300• BAR300•MET1000• MTD300• TCA1000)

IDUN SOLUTIONS LLC

Tricyclic antidepressant IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 00857275007117
• NIH Device Record Key: 12380930-1fe4-4421-b342-7d473f440c37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreChek
• Version Model Number: 21512050010308-A
• 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	00857275007117 [Package]; Contains: 00857275007575; Package: [25 Units]; In Commercial Distribution
GS1	00857275007575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153050

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-11-08
• Device Publish Date: 2018-08-02

On-Brand Devices [PreChek]

• 00857275007117: 12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300•
• 00857275007421: 12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300•