ATTEST Drug Screen Dip Card P-ATCard-01-6AM

GUDID B115PATCARD016AM0

6AM10

ADVIN BIOTECH, INC.

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• Primary Device ID: B115PATCARD016AM0
• NIH Device Record Key: 3d64e987-98f9-499f-9d8c-2cf0f2f70088
• Commercial Distribution Discontinuation: 2080-09-22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ATTEST Drug Screen Dip Card
• Version Model Number: 1
• Catalog Number: P-ATCard-01-6AM
• 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	B115PATCARD016AM0 [Unit of Use]
HIBCC	B115PATCARD016AM1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182123

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: 2022-09-30
• Device Publish Date: 2022-09-22

Devices Manufactured by ADVIN BIOTECH, INC.

• 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
• B115SECARD12020 - Sienna Multi-Drug Test Dip Card: 2022-10-28 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50
• B115SECUP12020 - Sienna Multi-Drug Test Cup: 2022-10-28 AMP500/BAR300/BUP10/BZO300/COC150/MDMA500/MET500/MTD300/OPI300/OXY100/PCP25/THC50
• B115PATCARD016AM0 - ATTEST Drug Screen Dip Card: 2022-09-306AM10
• B115PATCARD016AM0 - ATTEST Drug Screen Dip Card: 2022-09-30 6AM10
• B115APCUP10260 - Multi Drug Screen Test Pro Cup: 2022-03-28 AMP1000/BAR300/BZO300/COC300/MET1000/MTD300/OPI2000/OXY100/PCP25/THC50
• B115APCUPD12740 - Multi Drug Screen Test Pro Cup with AD: 2022-03-28 AMP1000/BAR300/BUP10/BZO300/COC300/MDMA500/MET1000/MTD300/OPI300/OPI2000/OXY100/THC50(pH/OX/CR)