Sienna Multi-Drug Test Cup SECup-12-02

GUDID B115SECUP12020

AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50

ADVIN BIOTECH, INC.

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

• Primary Device ID: B115SECUP12020
• NIH Device Record Key: 0bab3e9d-0e8a-4bc7-ba44-b898cd268caa
• Commercial Distribution Discontinuation: 2080-10-20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sienna Multi-Drug Test Cup
• Version Model Number: 1
• Catalog Number: SECup-12-02
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B115SECUP12020 [Unit of Use]
HIBCC	B115SECUP12021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122809

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

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: 2022-10-28
• Device Publish Date: 2022-10-20

Devices Manufactured by ADVIN BIOTECH, INC.

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• B115ABCASS1CANAO1 - Advin COVID-19 Antigen Test @Home: 2024-08-28
• 10840050517496 - Precision Plus Multi Panel Urine Drug Test Cup: 2024-05-31 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50
• 10840050517526 - Precision Plus Multi Panel Urine Drug Test Cup: 2024-05-31 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI2000/OXY100/PCP25/THC50
• 00840050517536 - Precision Plus Multi Panel Urine Drug Test Cup: 2024-05-31 AMP500/BAR300/BUP10/BZO300/COC150/EDDP300/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/TCA1000/THC50
• B115SECARD01THC500 - Sienna Multi-Drug Test Dip Card: 2022-10-28 THC50
• B115SECARD05090 - Sienna Multi-Drug Test Dip Card: 2022-10-28 AMP500/COC150/OPI2000/PCP25/THC50
• B115SECARD06100 - Sienna Multi-Drug Test Dip Card: 2022-10-28 AMP500/BZO300/COC150/MET500/OPI2000/THC50