iScreen 88019

GUDID 00810042683518

iScreen™ Urine Adulteration Controls, 2x20mL kitbox

BIOCHEMICAL DIAGNOSTICS INC

Multiple urine analyte IVD, control

• Primary Device ID: 00810042683518
• NIH Device Record Key: ae41b315-e139-444e-8d50-7a3c3993c485
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iScreen
• Version Model Number: 88019
• Catalog Number: 88019
• Company DUNS: 028007698
• Company Name: BIOCHEMICAL DIAGNOSTICS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com
• Phone: 631-595-9200
• Email: support@biochemicaldiagnostics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810042683518 [Primary]

FDA Product Code

• OHQ: Multi-Analyte Controls Unassayed

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: 2023-06-21
• Device Publish Date: 2023-06-13

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