| Primary Device ID | 20850041721136 |
| NIH Device Record Key | 5704e85a-7fc3-402b-b489-02606da0f998 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HealthConfirm |
| Version Model Number | CB-HC-Cassette-Covid Flu A/B (OTC) 4PACK |
| 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 | 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 | false |
| OTC Over-The-Counter | true |
| Phone | 1-800-908-5603 |
| cs@confirmbiosciences.com | |
| Phone | 1-800-908-5603 |
| cs@confirmbiosciences.com | |
| Phone | 1-800-908-5603 |
| cs@confirmbiosciences.com | |
| Phone | 1-800-908-5603 |
| cs@confirmbiosciences.com | |
| Phone | 1-800-908-5603 |
| cs@confirmbiosciences.com | |
| Phone | 1-800-908-5603 |
| cs@confirmbiosciences.com | |
| Phone | 1-800-908-5603 |
| cs@confirmbiosciences.com | |
| Phone | 1-800-908-5603 |
| cs@confirmbiosciences.com | |
| Phone | 1-800-908-5603 |
| cs@confirmbiosciences.com | |
| Phone | 1-800-908-5603 |
| cs@confirmbiosciences.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850041721132 [Primary] |
| GS1 | 20850041721136 [Package] Contains: 00850041721132 Package: Case [24 Units] In Commercial Distribution |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-22 |
| Device Publish Date | 2025-09-12 |
| 00856464008683 | This test has not been FDA cleared or approved. This test has been authorized by FDA under an EU |
| 20850041721136 | HealthConfirm Covid/ Flu Combo Test 4 Pack |
| 20850041721129 | HealthConfirm Covid/ Flu Combo Test 2 Pack |
| 00850041721118 | HealthConfirm Covid/ Flu Combo Test |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEALTHCONFIRM 87682011 5539196 Live/Registered |
CONFIRM BIOSCIENCES, INC. 2017-11-13 |