SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)

GUDID 10810124273085

ALERE SAN DIEGO, INC.

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• Primary Device ID: 10810124273085
• NIH Device Record Key: 28ff9a78-8008-40dd-9cd3-7e7ce7bb8427
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureStepTM Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)
• Version Model Number: DTC-101-a-Sgl
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, 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: 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	00810124273088 [Primary]
GS1	10810124273085 [Unit of Use]

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

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

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