CERTUM One Step Multi-Line Drug Screen EZ Split 4565151326

GUDID 10810124274518

++++

ALERE SAN DIEGO, INC.

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

• Primary Device ID: 10810124274518
• NIH Device Record Key: 2534e034-3cca-4018-a69e-3264f8ba02db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CERTUM One Step Multi-Line Drug Screen EZ Split
• Version Model Number: DBO-157-012-a
• Catalog Number: 4565151326
• 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: 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	00810124274511 [Primary]
GS1	10810124274518 [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: 2024-10-18
• Device Publish Date: 2024-10-10

On-Brand Devices [CERTUM One Step Multi-Line Drug Screen EZ Split]

• 10810124274518: ++++
• 10810124273825: (AMP1000/COC300/THC50)+( mAMP1000/OPl2000/PCP25)+(BZO300/TCA1000/BAR300)+
• 10810124273818: ++< mAMP1000>++ +
• 10810124273801: ++++
• 10810124273795: ++< THC50>
• 10810124272972: ++< mAMP1000>++ +