InstaTest™ 121151-1-44

GUDID 00850054026323

Fentanyl RapiCard InstaTest

Diagnostic Automation, Inc.

Fentanyl IVD, kit, rapid ICT, clinical

• Primary Device ID: 00850054026323
• NIH Device Record Key: a85654b9-9a4f-4982-af79-33e6418c9985
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InstaTest™
• Version Model Number: DACD121151-1-44
• Catalog Number: 121151-1-44
• Company DUNS: 878252071
• Company Name: Diagnostic Automation, 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com
• Phone: 8185913030
• Email: OneStep@rapidtest.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850054026323 [Primary]

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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: 2023-10-16
• Device Publish Date: 2023-10-06

On-Brand Devices [InstaTest™]

• 00894175000619: ASO Latex Test Kit: Diagnostic Automation Inc. Latex agglutination slide test for the Qualitativ
• 00850054026323: Fentanyl RapiCard InstaTest