Healgen (Private Label) - 254

GUDID 00895330002806

5 Panel Clia Cup COC/THC/OPI/AMP/mAMP

CONFIRM BIOSCIENCES, INC.

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

• Primary Device ID: 00895330002806
• NIH Device Record Key: 949ea72a-b999-4f88-b637-f27685e478af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Healgen (Private Label) - 254
• Version Model Number: CB-HE-CUP-254
• 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	00895330002806 [Primary]

FDA Product Code

• DJG: Enzyme Immunoassay, Opiates
• NFT: Test, Amphetamine, Over The Counter

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

On-Brand Devices [Healgen (Private Label) - 254]

• 00895330002806: 5 Panel Clia Cup COC/THC/OPI/AMP/mAMP
• 00895330002707: 5 Panel Dip Card - CLIA COC/AMP/mAMP/THC/OPI