SureStepTM Urine Drug Test Cassette

GUDID 10810124273290

ALERE SAN DIEGO, INC.

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

• Primary Device ID: 10810124273290
• NIH Device Record Key: 7b030260-f91f-4f1f-a6e3-cfe74e406fbb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureStepTM Urine Drug Test Cassette
• Version Model Number: DCO-U102a
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, INC.
• Device Count: 40
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810124273293 [Primary]
GS1	10810124273290 [Unit of Use]

FDA Product Code

• DIO: Enzyme Immunoassay, Cocaine And Cocaine Metabolites

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: 2023-12-25
• Device Publish Date: 2023-12-15

On-Brand Devices [SureStepTM Urine Drug Test Cassette]

• 10815845025180: DOP-102
• 10810124273337: DTH-102a
• 10810124273313: DMD-102a
• 10810124273290: DCO-U102a
• 10810124273252: DAM-A102a