SureStep™ Urine Test Drug Screen Strip 4561029002

GUDID 10815845024237

SureStep™ Urine Test Drug Screen Strip, Opiate (MOP 300)

ALERE SAN DIEGO, INC.

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

• Primary Device ID: 10815845024237
• NIH Device Record Key: 7cc46cc4-bcaf-41b7-9568-8262638956db
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureStep™ Urine Test Drug Screen Strip
• Version Model Number: DMO-101
• Catalog Number: 4561029002
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, INC.
• Device Count: 50
• 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	00815845024230 [Primary]
GS1	10815845024237 [Unit of Use]

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates

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 [SureStep™ Urine Test Drug Screen Strip]

• 10815845024404: SureStep™ Urine Test Drug Screen Strip, Methamphetamine (MET 1000)
• 10815845024398: SureStep™ Urine Test Drug Screen Strip, Opiate (OPI 2000)
• 10815845024381: Amphetamine (AMP 1000)
• 10815845024305: SureStep™ Urine Test Drug Screen Strip Benzodiazepines (BZO 300)
• 10815845024299: SureStep™ Urine Test Drug Screen Strip, Marijuana (THC 50)
• 10815845024275: SureStep™ Urine Test Drug Screen Strip, Methadone (MTD 300)
• 10815845024268: SureStep™ Urine Test Drug Screen Strip, Oxycodone (OXY 100)
• 10815845024237: SureStep™ Urine Test Drug Screen Strip, Opiate (MOP 300)
• 10815845024220: SureStep™ Urine Test Drug Screen Strip, Methylenedioxymethamphetamine (MDMA 500)
• 10815845023797: SureStep™ Urine Test Drug Screen Strip, Tricyclic Antidepressants (TCA 1000)
• 10815845023162: SureStep™ Urine Test Drug Screen Strip, Phencyclidine (PCP 25)
• 10815845023155: SureStep™ Urine Test Drug Screen Strip, Barbiturate (BAR300)
• 10815845023148: SureStep™ Urine Test Drug Screen Strip, Cocaine (COC300)