Advin Multi-Drug Screen Test ABCard-05-45

GUDID B115ABCARD05451

AMP500/BZO300/COC150/MET500/OPI2000

ADVIN BIOTECH, INC.

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• Primary Device ID: B115ABCARD05451
• NIH Device Record Key: 838250b1-4256-402a-ae58-dcdf5683f6e4
• Commercial Distribution Discontinuation: 2080-01-01
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advin Multi-Drug Screen Test
• Version Model Number: ABCard-05-45
• Catalog Number: ABCard-05-45
• 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

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
HIBCC	B115ABCARD05450 [Unit of Use]
HIBCC	B115ABCARD05451 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

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: 2019-10-03
• Device Publish Date: 2019-09-25

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

• B115ATCUP07091: AMP500/BUP10/COC150/MET500/MOR300/OXY100/THC50
• B115ATCUP06201: AMP500/COC150/MET500/OPI2000/PCP25/THC50
• B115ATCUP06011: AMP500/BZO300/COC150/MET500/MOR300/THC50
• B115ATCUP05101: AMP500/COC150/MET500/OPI2000/THC50
• B115ATCUP05021: AMP500/COC150/MET500/MOR300/THC50
• B115ATCARD06011: AMP500/BZO300/COC150/MET500/MOR300/THC50
• B115ATCARD05231: AMP500/COC150/MET500/PCP25/THC50
• B115ATCARD05101: AMP500/COC150/MET500/OPI2000/THC50
• B115ATCARD05021: AMP500/COC150/MET500/MOR300/THC50
• B115ABCUPH10131: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/PCP25/THC50
• B115ABCUPD12061: AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50/(CR/OX/pH)
• B115ABCUPD12021: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/(CR/OX/pH)
• B115ABCUPC12021: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr
• B115ABCUPC10131: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
• B115ABCUPC06081: AMP500/COC150/MDMA500/OPI2000/PCP25/THC50/(Ox/SG/pH)/(Cr/Ni/Gl)
• B115ABCUPC05361: BZO300/COC150/MDMA500/OPI300/THC50/(Ox/SG/pH/Cr/Ni/Gl)
• B115ABCUPB12021: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50/GL/NI/CR
• B115ABCUPB09071: AMP500/BUP10/BZO300/COC150/MET500/MTD300/OPI300/OXY100/THC50/GL/NI/CR
• B115ABCUPA14031: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/TCA1000/THC50
• B115ABCUPA14021: AMP/BAR/BUP/BZO/COC/MDMA/MET/MTD/PCP/PPX/OXY/TCA/THC/OPI2000/(OX/pH/SG)
• B115ABCUPA13051: AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/PCP/PPX/OXY/TCA/THC/(OX/pH/SG)
• B115ABCUPA13011: AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/TCA/THC/(OX/pH/SG)
• B115ABCUPA12211: AMP500/BAR300/BUP10/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50/(OX/pH/SG)
• B115ABCUPA12191: AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/OPI300/OXY100/PCP25/THC50/(OX/pH/SG)
• B115ABCUPA12131: AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/TCA1000/THC50/(OX/pH/SG)
• B115ABCUPA12101: AMP500/BZO300/COC150/ETG/K2/MDMA/MET500/MOR300/OXY/PCP/THC/(OX/pH/SG)
• B115ABCUPA12021: AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/PCP/THC/(OX/pH/SG)
• B115ABCUPA12011: AMP/BAR/BUP/BZO/COC/MDMA/MET/MOR/MTD/OXY/TCA/THC/(OX/pH/SG)
• B115ABCUPA11251: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/OXY100/PCP25/PPX300/THC50/(OX/pH/SG)
• B115ABCUPA11181: AMP500/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/MTD300/OPI300/OXY100/THC50/(OX/pH/SG)
• B115ABCUPA11131: AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MOR300/MTD300/OXY100/PCP25/TCA1000/(OX/pH/SG)
• B115ABCUPA11071: AMP/BAR/BZO/COC/MDMA/MET/MOR/MTD/PCP/PPX/THC/(OX/pH/SG)
• B115ABCUPA11041: AMP/BAR/BUP/BZO/COC/EDDP/MET/MTD/OPI/OXY/THC/(OX/pH/SG)
• B115ABCUPA10341: AMP500/BAR300/BUP10/BZO300/COC150/MET500/MTD300/OPI300/OXY100/THC50/(OX/pH/SG)
• B115ABCUPA10311: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI300/OXY100/TCA1000/THC50/(OX/pH/SG)
• B115ABCUPA10301: BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MOR300/MTD300/OXY100/THC50
• B115ABCUPA10271: AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/THC50/(OX/pH/SG)
• B115ABCUPA10191: AMP500/BAR300/BZO300/COC150/MDMA/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
• B115ABCUPA10141: BAR300/BZO300/BUP10/COC150/MET500/MTD300/OPI2000/OXY100/TCA1000//THC50/(OX/pH/SG)
• B115ABCUPA10131: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/PCP25/THC50/(OX/pH/SG)
• B115ABCUPA10121: AMP500/BAR300/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/PCP25/THC50/(OX/pH/SG)
• B115ABCUPA10111: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/TCA1000/THC50/(OX/pH/SG)
• B115ABCUPA10101: (AMP500/OPI2000)/(COC/THC)/(MET/PCP)/BAR300/BZO300/MTD/PPX/(OX/pH/SG)
• B115ABCUPA10091: AMP500/BAR300/BUP10/BZO300/COC150/MET500/MOR300/MTD/OXY/THC/(OX/pH/SG)
• B115ABCUPA10061: AMP/BAR/BZO/COC/MET/MTD/OPI/PCP/PPX/THC/(OX/pH/SG)
• B115ABCUPA09071: AMP500/BUP10/BZO300/COC150/MET500/MOR300/MTD300/OXY100/THC50/(OX/pH/SG)
• B115ABCUPA09061: AMP500/BAR300/BZO300/COC150/MET500/MTD300/OPI2000/PCP25/THC50/(OX/pH/SG)
• B115ABCUPA09031: AMP/BUP/BZO/COC/EDDP/MOR/MTD/OXY/THC/(OX/pH/SG)
• B115ABCUPA08151: AMP500/BUP10/BZO300/COC150/MET500/MOR300/OXY100/THC50/(OX/pH/SG)
• B115ABCUPA08141: AMP500/BZO300/COC150/MET500/MTD300/OPI2000/OXY100/THC50/(OX/pH/SG)