HealthConfirm

GUDID 00856464008683

This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by Clinical Reference Laboratory, Inc. located in Lenexa, KS. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.

CONFIRM BIOSCIENCES, INC.

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• Primary Device ID: 00856464008683
• NIH Device Record Key: d042c6a5-f6e5-4bea-afe7-ccff22a29cfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthConfirm
• Version Model Number: COVIDRev061620
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856464008683 [Primary]

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: 2020-12-21
• Device Publish Date: 2020-12-11

Devices Manufactured by CONFIRM BIOSCIENCES, INC.

• 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
• 00895330002264 - DrugConfirm™ Single Panel Marijuana Testing Kit: 2021-05-24 DrugConfirm™ 1 Panel is the ideal drug testing solution for individuals that want a fast and accurate instant drug test which