UCP Home U-BZO-101

GUDID 20817038021242

UCP Home Drug Screening Test Strips Benzodiazepines Test Strip

UCP BIOSCIENCES, INC.

Benzodiazepine group IVD, kit, rapid ICT, clinical

• Primary Device ID: 20817038021242
• NIH Device Record Key: 166c4a24-1baf-4aaf-ad6a-afda18ad8096
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UCP Home
• Version Model Number: U-BZO-101
• Catalog Number: U-BZO-101
• Company DUNS: 163610020
• Company Name: UCP BIOSCIENCES, INC.
• Device Count: 50
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: true

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817038021248 [Unit of Use]
GS1	10817038021245 [Primary]
GS1	20817038021242 [Package]; Contains: 10817038021245; Package: case [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050540

FDA Product Code

• JXM: Enzyme Immunoassay, Benzodiazepine

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-10
• Device Publish Date: 2016-12-05

On-Brand Devices [UCP Home]

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• 20817038021242: UCP Home Drug Screening Test Strips Benzodiazepines Test Strip
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• 20817038021228: UCP Home Drug Screening Test Strips Cocaine Test Strip
• 20817038021266: UCP HOME Pregnancy Test Strip
• 20817038021211: UCP HOME Pregnancy Test Strip