Advin Multi-Drug Screen Test with SVT ABCupC-07-43

GUDID B115ABCUPC07430

BZO300/COC150/MET500/OPI300/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)

ADVIN BIOTECH, INC.

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

• Primary Device ID: B115ABCUPC07430
• NIH Device Record Key: d9ff27e9-b525-4ce4-9664-57a4eaab70a0
• Commercial Distribution Discontinuation: 2080-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advin Multi-Drug Screen Test with SVT
• Version Model Number: ABCupC-07-43
• Catalog Number: ABCupC-07-43
• Company DUNS: 006463333
• Company Name: ADVIN BIOTECH, 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: 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: true

Customer Support Contacts

• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.com
• Phone: (855)866-8382
• Email: info@advinbio.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
• 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
HIBCC	B115ABCUPC07430 [Unit of Use]
HIBCC	B115ABCUPC07431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

FDA Product Code

• JXM: Enzyme Immunoassay, Benzodiazepine

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: 2021-02-23
• Device Publish Date: 2021-02-15

On-Brand Devices [Advin Multi-Drug Screen Test with SVT]

• B115ABCUPD10161: AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50/(CR/OX/Ph)
• B115ABCUPD05021: AMP500/COC150/MET500/OPI300/THC50/(CR/OX/Ph)
• B115ABCUPA05091: AMP500/COC150/OPI2000/PCP25/THC50/(OX/pH/SG)
• B115ABCARDD10161: AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/THC50/(CR/OX/pH)
• B115ABCARDD05021: AMP500/COC150/MET500/OPI300/THC50/(CR/OX/pH)
• B115ABCUPE05021: AMP500/COC150/MET500/OPI300/THC50/(CR/SG/pH)
• B115ABCARDE05021: AMP500/COC150/MET500/OPI300/THC50/(CR/SG/pH)
• B115ABCUPD12011: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(CR/OX/pH)
• B115ABCARDD12011: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50
• B115ABCUPA11390: AMP500/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(OX/pH/SG)
• B115ABCARDA11390: AMP500/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(OX/pH/SG)
• B115ABCUPC12710: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/Ox/SG/pH/Cr/N
• B115ABCUPC12440: AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50/Ox/SG/pH/Cr/N
• B115ABCARDC12710: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/Ox/SG/pH/Cr/N
• B115ABCARDC12440: AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50/Ox/SG/pH/Cr/N
• B115ABCUPC07430: BZO300/COC150/MET500/OPI300/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
• B115ABCARDC07430: BZO300/COC150/MET500/OPI300/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
• B115ABCUPE12021: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/(CR/SG/pH)
• B115ABCUPC07031: AMP500/BZO300/COC150/MET500/OPI300/OXY100/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
• B115ABCARDE12021: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/(CR/SG/pH)
• B115ABCARDC07031: AMP500/BZO300/COC150/MET500/OPI300/OXY100/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)