OEM 81-13 Drug Test U-DOA-134

GUDID 20817038022126

OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC

UCP BIOSCIENCES, INC.

Amphetamine/methamphetamine group IVD, kit, rapid ICT, clinical

• Primary Device ID: 20817038022126
• NIH Device Record Key: e9b545c4-ef04-420c-9fec-9331dc428bf7
• Commercial Distribution Discontinuation: 2033-04-06
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OEM 81-13 Drug Test
• Version Model Number: U-DOA-134
• Catalog Number: U-DOA-134
• 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
• 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	00817038022122 [Unit of Use]
GS1	10817038022129 [Primary]
GS1	20817038022126 [Package]; Contains: 10817038022129; Package: case [50 Units]; Discontinued: 2023-04-06; Not 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: 2023-04-17
• Device Publish Date: 2023-04-07

On-Brand Devices [OEM 81-13 Drug Test ]

• 20817038022164: OEM 81-13 Drug Test 4 Panel Dip Card AMP/COC/THC/MET
• 20817038022157: OEM 81-13 Drug Test 6 Panel Dip Card AMP/COC/THC/MET/BZO/OPI
• 20817038022140: OEM 81-13 Drug Test 5 Panel Dip Card AMP/COC/THC/MET/OPI
• 20817038022133: OEM 81-13 Drug Test 5 Panel Dip Card AMP/COC/THC/MET/BZO
• 20817038022126: OEM 81-13 Drug Test 3 Panel Dip Card AMP/COC/THC