CERTUM One Step Multi-Drug Screen Panel 4566601326

GUDID 10810124273849

COC300/AMP1000/mAMP1000/THC50/OPI2000/BZO300

ALERE SAN DIEGO, INC.

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

• Primary Device ID: 10810124273849
• NIH Device Record Key: 1c94ecf2-9837-4bf4-b668-7114958b5eda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERTUM One Step Multi-Drug Screen Panel
• Version Model Number: DOA-154-061-a
• Catalog Number: 4566601326
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, INC.
• Device Count: 25
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810124273842 [Primary]
GS1	10810124273849 [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: 2024-12-25
• Device Publish Date: 2024-12-17

On-Brand Devices [CERTUM One Step Multi-Drug Screen Panel]

• 10810124273870: COC300/THC50
• 10810124273863: COC300/AMP1000/THC50
• 10810124273856: COC300/AMP1000/mAMP1000/THC50/OPI2000
• 10810124273849: COC300/AMP1000/mAMP1000/THC50/OPI2000/BZO300
• 10810124273832: COC300/AMP1000/mAMP1000/THC50/OPI2000/BZO300