SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup 4566399019

GUDID 10810124273634

+++++

ALERE SAN DIEGO, INC.

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

• Primary Device ID: 10810124273634
• NIH Device Record Key: 3add4732-2be0-46a2-845e-1c2c050cd0a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup
• Version Model Number: DBO-167-301
• Catalog Number: 4566399019
• 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	00810124273637 [Primary]
GS1	10810124273634 [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: 2024-09-25
• Device Publish Date: 2024-09-17

On-Brand Devices [SureStep™ Urine Test E-Z Split Key™ Drug Screen Cup]

• 10810124273689: +(MDMA500/MOP300/PCP25)+(BZO300/TCA1000/BAR300)+(AMP1000/COC300/THC50)
• 10810124273672: (Oxidants/Specific Gravity/pH)+(Nitrite/Glutaraldehyde/Creatinine)++(MET1000/OPI2000/PCP
• 10810124273665: (AMP1000/COC300/THC50)+(MET1000/OPI2000/PCP25)+(BZO300/TCA1000/BAR300)+
• 10810124273658: (AMP1000/COC300/THC50)+(MET1000/OPI2000/PCP25)+(BZO300/BAR300)
• 10810124273641: (OPI2000/MDMA500)+++++
• 10810124273634: +++++
• 10810124273627: +++++
• 10810124273610: +++(AMP1000/OPI2000)
• 10810124273603: ++++
• 10810124273597: (MET1000/COC300/THC50)++
• 10810124273580: ++++
• 10810124273573: ++
• 10810124273566: ++
• 10810124273177: (AMP1000/COC300/THC50)+(MET1000/OPI2000/PCP25)+(BZO300/TCA1000/BAR300)+
• 10810124273160: (AMP1000/COC300/THC50)+(MET1000/OPI2000/PCP25)+(BZO300/BAR300)++
• 10810124273153: +++++
• 10810124273146: ++++