Healgen (Private Label) - 4104

GUDID 00895330002783

10 Panel Dip Card - CLIA - AMP/THC/COC/OPI/PCP/BZO/BARB/MTD/mAMP/OXY

CONFIRM BIOSCIENCES, INC.

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

• Primary Device ID: 00895330002783
• NIH Device Record Key: 3eabb171-b070-49bb-bd43-b930218726e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healgen (Private Label) - 4104
• Version Model Number: CB-HE-4104
• Company DUNS: 806524968
• Company Name: CONFIRM BIOSCIENCES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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
GS1	00895330002783 [Primary]

FDA Product Code

• DJF: Gas Chromatography, Opiates

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-05-24
• Device Publish Date: 2016-11-15

Devices Manufactured by CONFIRM BIOSCIENCES, INC.

• 00856464008584 - Healgen (Private Label) - 253: 2024-10-07 Healgen (DrugConfirm) - NO THC + PCP - 5 Panel Clicker Cup Test: AMP1000/COC300/mAMP1000/MOP2000/PCP25
• 00856464008416 - DrugConfirm: 2022-11-02 1 Drug Tested Home Drug Test (THC)
• 10856464008505 - DrugConfirm: 2022-11-02 1 Drug Tested Home Drug Test (THC) 2 Pack
• 00856464008409 - DrugConfirm: 2022-11-01 4 Drugs Tested Home Drug Test
• 00856464008423 - DrugConfirm: 2022-11-01 7 Drugs Tested Home Drug Test
• 00856464008430 - DrugConfirm: 2022-11-01 14 Drugs Tested Home Drug Test
• 00856464008447 - DrugConfirm: 2022-11-01 1 Drug Tested Home Drug Test (COC)
• 00895330002073 - DrugConfirm Advanced™ 6 Panel Instant Drug Test: 2021-05-24 This kit tests for: Cocaine (COC), Marijuana (THC), Opiates (OPI), Methamphetamines (mAMP), Amphetamines (AMP), Phencyclidine (P