Sienna Multi-Drug Test Dip Card SECard-05-09

GUDID B115SECARD05090

AMP500/COC150/OPI2000/PCP25/THC50

ADVIN BIOTECH, INC.

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

• Primary Device ID: B115SECARD05090
• NIH Device Record Key: 2f2935df-3ef4-411d-baf0-6e19b4c6793c
• Commercial Distribution Discontinuation: 2080-10-20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sienna Multi-Drug Test Dip Card
• Version Model Number: 1
• Catalog Number: SECard-05-09
• 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	B115SECARD05090 [Unit of Use]
HIBCC	B115SECARD05091 [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

On-Brand Devices [Sienna Multi-Drug Test Dip Card]

• B115SECARD12020: AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50
• B115SECARD06100: AMP500/BZO300/COC150/MET500/OPI2000/THC50
• B115SECARD05090: AMP500/COC150/OPI2000/PCP25/THC50
• B115SECARD01THC500: THC50