CERTUM mAMP One Step Methamphetamine Test Strip

GUDID 10810124273757

ALERE SAN DIEGO, INC.

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

• Primary Device ID: 10810124273757
• NIH Device Record Key: 579f3e39-b0d6-45fe-9d41-3bd566f43a2b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERTUM mAMP One Step Methamphetamine Test Strip
• Version Model Number: DME-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	00810124273750 [Primary]
GS1	10810124273757 [Unit of Use]

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

On-Brand Devices [CERTUM mAMP One Step Methamphetamine Test Strip]

• 10810124273764: DME-U101-a-Sgl
• 10810124273757: DME-101-a-Sgl