AIDTEQ Rapid Multi-Drug Test Dip Card DOA-3174-061

GUDID 10817038022020

AIDTEQ Rapid Multi-Drug Test Dip Card (AMP/BZO/COC/MDMA/MTD/OPI/THC)

UCP BIOSCIENCES, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10817038022020
• NIH Device Record Key: 463f6dc8-1fba-4d30-ad97-2437536cfa30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIDTEQ Rapid Multi-Drug Test Dip Card
• Version Model Number: DOA-3174-061
• Catalog Number: DOA-3174-061
• Company DUNS: 163610020
• Company Name: UCP BIOSCIENCES, INC.
• Device Count: 5
• 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
• 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	00817038022023 [Unit of Use]
GS1	10817038022020 [Primary]
GS1	20817038022027 [Package]; Package: Case [150 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131811

FDA Product Code

• DJC: Thin Layer Chromatography, Methamphetamine

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: 2020-03-09
• Device Publish Date: 2020-02-29

Devices Manufactured by UCP BIOSCIENCES, INC.

• 20817038022249 - inSight 12 Panel Drug Test Cup: 2024-05-24 inSight 12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
• 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
• 20817038022218 - u-CardTM Drug Test Screen 12 Panel Test Card: 2024-01-12 u-CardTM Drug Test Screen 12 Panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
• 20817038022201 - UCP: 2023-12-18 UCP Drug Test Mini Cups 9-Panel Drug Test Mini Cup AMP/BAR/BZO/COC/MDMA/MTD/OPI/PCP/PPX
• 20817038021020 - UCP Home Pregnancy Dip Card: 2023-07-06 Pregnancy Dip Card
• 20817038021211 - UCP HOME: 2023-07-06 UCP HOME Pregnancy Test Strip
• 20817038021266 - UCP Home: 2023-07-06 UCP HOME Pregnancy Test Strip