Status ASSURE 11125AA

GUDID 00868348000201

(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI300+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel Drug Test Card

Lifesign L.L.C.

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

• Primary Device ID: 00868348000201
• NIH Device Record Key: 0fcaccde-2636-4a8a-a831-51ce31a444d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Status ASSURE
• Version Model Number: 11125AA
• Catalog Number: 11125AA
• Company DUNS: 010964864
• Company Name: Lifesign L.L.C.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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

Customer Support Contacts

• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com
• Phone: 1-800-526-2125
• Email: info@lifesignmed.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00868348000201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113046

FDA Product Code

• LFG: Radioimmunoassay, Tricyclic Antidepressant Drugs

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: 2018-07-06
• Device Publish Date: 2016-09-01

On-Brand Devices [Status ASSURE ]

• 00868348000249: AMP/COC/MET1000/OPI2000/PCP/THC with Cr, Ni, pH, Bl, S.G. 6 Panel Drug Test Cup
• 00868348000232: MET1000+OPI2000+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel
• 00868348000225: MET1000+OPI300+TCA+(BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP) with Cr, Ni, pH, Bl, S.G. 11 Panel D
• 00868348000218: (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI2000+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel
• 00868348000201: (BZO/BAR)+(COC/THC)+(OXY/MDMA)+(PCP/AMP)+MET1000+OPI300+TCA with Cr, Ni, pH, Bl, S.G. 11 Panel D