iScreen 88006

GUDID 00810042683501

iScreen™ Urine Drug Screen Controls, Negative and Cotinine Positive, 2x5mL kitbox

BIOCHEMICAL DIAGNOSTICS INC

Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control Multiple drugs of abuse IVD, control

• Primary Device ID: 00810042683501
• NIH Device Record Key: 46bdfb88-5cc5-4530-bc0f-f29956239168
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iScreen
• Version Model Number: 88006
• Catalog Number: 88006
• 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	00810042683501 [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: 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