SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200)

GUDID 10810124273306

ALERE SAN DIEGO, INC.

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

• Primary Device ID: 10810124273306
• NIH Device Record Key: 0e5bc39e-73ec-4c9c-8399-a059dba5cb0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureStep™ Urine Test Drug Screen Cassette, Cotinine (COT 200)
• Version Model Number: DCT-102a
• 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: 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	00810124273309 [Primary]
GS1	10810124273306 [Unit of Use]

FDA Product Code

• MKU: Enzyme Immunoassay, Nicotine And Nicotine 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: 2023-12-25
• Device Publish Date: 2023-12-15

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 +++++