DrugConfirm™ 4 Panel Instant Drug Test

GUDID 00895330002318

This urine test kit detects 4 drugs: Cocaine (COC), Marijuana (THC), Opiates (OPI) including Heroin, Amphetamines (AMP)

CONFIRM BIOSCIENCES, INC.

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

• Primary Device ID: 00895330002318
• NIH Device Record Key: 87b30833-a410-4dbe-8b1c-fe7392e83ad7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DrugConfirm™ 4 Panel Instant Drug Test
• Version Model Number: 03-5201
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00895330002318 [Primary]

FDA Product Code

• DKZ: Enzyme Immunoassay, Amphetamine

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: 2016-09-06

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