SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 300)

GUDID 10810124272989

ALERE SAN DIEGO, INC.

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

• Primary Device ID: 10810124272989
• NIH Device Record Key: 08136073-4e5e-4bd3-8087-0c5c63bf39d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureStepTM Urine Test Drug Screen Strip, Amphetamine (AMP 300)
• Version Model Number: DAM-A101-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	00810124272982 [Primary]
GS1	10810124272989 [Unit of Use]

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

Devices Manufactured by ALERE SAN DIEGO, INC.

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• 10810124273856 - CERTUM One Step Multi-Drug Screen Panel: 2024-12-25 COC300/AMP1000/mAMP1000/THC50/OPI2000
• 10810124273863 - CERTUM One Step Multi-Drug Screen Panel: 2024-12-25 COC300/AMP1000/THC50
• 10810124273870 - CERTUM One Step Multi-Drug Screen Panel: 2024-12-25 COC300/THC50
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