OEM 81-13 Drug Test 5 Panel Test Cup U-CUP-654

GUDID 20817038022225

OEM 81-13 Drug Test 5 Panel Test Cup AMP/COC/THC/MET/BZO

UCP BIOSCIENCES, INC.

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

• Primary Device ID: 20817038022225
• NIH Device Record Key: 4f238358-6c54-4516-8d58-29f9f608d0ac
• Commercial Distribution Discontinuation: 2034-04-08
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OEM 81-13 Drug Test 5 Panel Test Cup
• Version Model Number: U-CUP-654
• Catalog Number: U-CUP-654
• Company DUNS: 163610020
• Company Name: UCP BIOSCIENCES, 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: 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
• 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	00817038022221 [Unit of Use]
GS1	10817038022228 [Primary]
GS1	20817038022225 [Package]; Contains: 10817038022228; Package: case [8 Units]; Discontinued: 2034-04-08; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131811

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: 2024-04-17
• Device Publish Date: 2024-04-09

Devices Manufactured by UCP BIOSCIENCES, INC.

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• 20817038022225 - OEM 81-13 Drug Test 5 Panel Test Cup: 2024-04-17OEM 81-13 Drug Test 5 Panel Test Cup AMP/COC/THC/MET/BZO
• 20817038022225 - OEM 81-13 Drug Test 5 Panel Test Cup: 2024-04-17 OEM 81-13 Drug Test 5 Panel Test Cup AMP/COC/THC/MET/BZO
• 20817038022232 - OEM 81-13 Drug Test 6 Panel Test Cup: 2024-04-17 OEM 81-13 Drug Test 6 Panel Test Cup AMP/COC/THC/MET/BZO/OPI
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