| Primary Device ID | 00856464008348 |
| NIH Device Record Key | ffad69bf-f91a-41ea-a436-4070a6934437 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Healgen (Private Label) - 242 |
| Version Model Number | CB-HE-CUP-242 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00856464008348 [Primary] |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-17 |
| Device Publish Date | 2019-10-09 |
| 00850041721118 - HealthConfirm | 2025-09-22 HealthConfirm Covid/ Flu Combo Test |
| 20850041721129 - HealthConfirm | 2025-09-22 HealthConfirm Covid/ Flu Combo Test 2 Pack |
| 20850041721136 - HealthConfirm | 2025-09-22 HealthConfirm Covid/ Flu Combo Test 4 Pack |
| 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 |