Multi Drug Screen Test Pro Cup with AD APCupD-12-74

GUDID B115APCUPD12740

AMP1000/BAR300/BUP10/BZO300/COC300/MDMA500/MET1000/MTD300/OPI300/OPI2000/OXY100/THC50(pH/OX/CR)

ADVIN BIOTECH, INC.

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

• Primary Device ID: B115APCUPD12740
• NIH Device Record Key: e456d2da-0eaf-473e-8b9d-d987bf22d057
• Commercial Distribution Discontinuation: 2080-03-18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi Drug Screen Test Pro Cup with AD
• Version Model Number: 1
• Catalog Number: APCupD-12-74
• 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: true
• OTC Over-The-Counter: false

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B115APCUPD12740 [Unit of Use]
HIBCC	B115APCUPD12741 [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: 2022-03-28
• Device Publish Date: 2022-03-18

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: 2022-09-30 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: 2022-03-28AMP1000/BAR300/BUP10/BZO300/COC300/MDMA500/MET1000/MTD300/OPI300/OPI2000/OXY100/THC50(pH/OX/CR)
• 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)