iCassette™ DCB-1115-011

GUDID 30817405022510

iCassette DOA Dev(Urine) 25T

Instant Technologies, Inc.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical

• Primary Device ID: 30817405022510
• NIH Device Record Key: 55509a9f-2cab-47c8-adea-3b669d89c918
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iCassette™
• Version Model Number: DCB-1115-011
• Catalog Number: DCB-1115-011
• Company DUNS: 019410187
• Company Name: Instant Technologies, Inc.
• Device Count: 25
• 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: false

Customer Support Contacts

• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com
• Phone: 1-800-340-4029
• Email: Qa.Portsmouth@abbott.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817405022519 [Primary]
GS1	10817405022516 [Unit of Use]
GS1	30817405022510 [Package]; Contains: 00817405022519; Package: Master Carton [12 Units]; In Commercial Distribution

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

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: 2023-02-09
• Device Publish Date: 2023-02-01

On-Brand Devices [iCassette™]

• 30817405022510: iCassette DOA Dev(Urine) 25T
• 30817405022671: iCassette DOA Multi-Dev(Urine) 25T
• 30817405022664: iCassette DOA Multi-Dev(Urine) 25T
• 30817405022657: iCassette DOA Multi-Dev(Urine) 25T
• 30817405022640: iCassette DOA Multi-Dev(Urine) 25T
• 30817405022633: iCassette DOA Multi-Dev(Urine) 25T
• 30817405022626: iCassette DOA Multi-Dev(Urine) 25T
• 30817405022619: iCassette DOA Multi-Dev(Urine) 25T
• 30817405022602: iCassette DOA Multi-Dev(Urine) 25T
• 30817405022596: iCassette MDMA Dev(Urine) 25T
• 30817405022589: iCassette OPI Dev(Urine) 25T
• 30817405022572: iCassette OXY Dev(Urine) 25T
• 30817405022565: iCassette BZO Dev(Urine) 25T
• 30817405022558: iCassette THC Dev(Urine) 25T
• 30817405022541: iCassette COC Dev(Urine) 25T
• 30817405022534: iCassette AMP Dev(Urine) 25T
• 30817405021667: iCassette COT Dev(Urine) 25T