iScreen 88036

GUDID 00810042684232

iSCREEN LC 2x10mL Kit

BIOCHEMICAL DIAGNOSTICS INC

Multiple drugs of abuse IVD, control

• Primary Device ID: 00810042684232
• NIH Device Record Key: 1a766d4c-7c40-4a30-ac34-0f8dbe4cc1eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iScreen
• Version Model Number: 88036
• Catalog Number: 88036
• Company DUNS: 028007698
• Company Name: BIOCHEMICAL DIAGNOSTICS INC
• 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: false
• Device Combination Product: false
• Single Use: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810042684232 [Primary]

FDA Product Code

• DIF: Drug Mixture Control Materials

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: 2024-07-30
• Device Publish Date: 2024-07-22

On-Brand Devices [iScreen]

• 00810042683617: Alere Professional cup 2x10 mL kitbox
• 00810042683556: iScreen™ Urine Drug Screen Controls, Negative and HIGH Positive, 2x20mL
• 00810042683549: iScreen™ Urine Drug Screen Controls, Negative and HIGH Positive, 2x5mL
• 00810042683518: iScreen™ Urine Adulteration Controls, 2x20mL kitbox
• 00810042683501: iScreen™ Urine Drug Screen Controls, Negative and Cotinine Positive, 2x5mL kitbox
• 00810042684232: iSCREEN LC 2x10mL Kit