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.

• 10810124273832 - CERTUM One Step Multi-Drug Screen Panel: 2024-12-25 COC300/AMP1000/mAMP1000/THC50/OPI2000/BZO300
• 10810124273849 - CERTUM One Step Multi-Drug Screen Panel: 2024-12-25 COC300/AMP1000/mAMP1000/THC50/OPI2000/BZO300
• 10810124273856 - CERTUM One Step Multi-Drug Screen Panel: 2024-12-25 COC300/AMP1000/mAMP1000/THC50/OPI2000
• 10810124273863 - CERTUM One Step Multi-Drug Screen Panel: 2024-12-25 COC300/AMP1000/THC50
• 10810124273870 - CERTUM One Step Multi-Drug Screen Panel: 2024-12-25 COC300/THC50
• 10815845023148 - SureStep™ Urine Test Drug Screen Strip: 2024-12-25 SureStep™ Urine Test Drug Screen Strip, Cocaine (COC300)
• 10815845023155 - SureStep™ Urine Test Drug Screen Strip: 2024-12-25 SureStep™ Urine Test Drug Screen Strip, Barbiturate (BAR300)
• 10815845023162 - SureStep™ Urine Test Drug Screen Strip: 2024-12-25 SureStep™ Urine Test Drug Screen Strip, Phencyclidine (PCP 25)