GUDID 10815845020383

ALERE SAN DIEGO, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10815845020383
• NIH Device Record Key: 1963a24d-e352-4873-a418-54339cb869ac
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: DCT-102
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, INC.
• Device Count: 40
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815845020386 [Unit of Use]
GS1	10815845020383 [Primary]

FDA Product Code

• MRS: Test System, Nicotine, Cotinine, Metabolites

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-05-24
• Device Publish Date: 2016-09-24

Devices Manufactured by ALERE SAN DIEGO, INC.

• 10810124272972 - CERTUM One Step Multi-Line Drug Screen EZ Split: 2024-10-18 ++< mAMP1000>++ +
• 10810124273795 - CERTUM One Step Multi-Line Drug Screen EZ Split: 2024-10-18 ++< THC50>
• 10810124273801 - CERTUM One Step Multi-Line Drug Screen EZ Split: 2024-10-18 ++++
• 10810124273818 - CERTUM One Step Multi-Line Drug Screen EZ Split: 2024-10-18 ++< mAMP1000>++ +
• 10810124273825 - CERTUM One Step Multi-Line Drug Screen EZ Split: 2024-10-18 (AMP1000/COC300/THC50)+( mAMP1000/OPl2000/PCP25)+(BZO300/TCA1000/BAR300)+
• 10810124274518 - CERTUM One Step Multi-Line Drug Screen EZ Split: 2024-10-18 ++++
• 10810124273146 - SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup: 2024-09-25 ++++
• 10810124273153 - SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup: 2024-09-25 +++++