PreChek

GUDID 00857275007421

12 Multi Drug Test Round Cup (AMP1000•COC300•OXY100•THC50•PCP25•MDMA500•MOP300• BZO300• BAR300•MET1000• MTD300•BUP10)

IDUN SOLUTIONS LLC

Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA) Buprenorphine IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00857275007421
• NIH Device Record Key: 100fae57-ff25-4998-a322-1c5118aefcd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreChek
• Version Model Number: 21512050010308
• 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	00857275007421 [Package]; Contains: 00857275007520; Package: [25 Units]; In Commercial Distribution
GS1	00857275007520 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153050

FDA Product Code

• DJR: Enzyme Immunoassay, Methadone

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•