| Primary Device ID | G474M321001EI0 |
| NIH Device Record Key | 58e44f3d-5420-4041-a45f-fcc635c97b4f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | mLife Verify |
| Version Model Number | M321001-EI |
| Company DUNS | 117581283 |
| Company Name | Mlife Diagnostics, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Phone | 833-654-3339 |
| support@mlifedx.com | |
| Phone | 833-654-3339 |
| support@mlifedx.com | |
| Phone | 833-654-3339 |
| support@mlifedx.com | |
| Phone | 833-654-3339 |
| support@mlifedx.com | |
| Phone | 833-654-3339 |
| support@mlifedx.com | |
| Phone | 833-654-3339 |
| support@mlifedx.com | |
| Phone | 833-654-3339 |
| support@mlifedx.com | |
| Phone | 833-654-3339 |
| support@mlifedx.com | |
| Phone | 833-654-3339 |
| support@mlifedx.com | |
| Phone | 833-654-3339 |
| support@mlifedx.com | |
| Phone | 833-654-3339 |
| support@mlifedx.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G474M321001EI0 [Primary] |
| HIBCC | G474M321001EI1 [Package] Package: Box [25 Units] In Commercial Distribution |
| PUX | Test, Amphetamine, Employment And Insurance Testing, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-06 |
| Device Publish Date | 2026-01-29 |
| G474M321001EI0 - mLife Verify | 2026-02-0610 Panel Oral Fluid Drug Test |
| G474M321001EI0 - mLife Verify | 2026-02-06 10 Panel Oral Fluid Drug Test |
| G474M3208010 - Verify | 2025-07-29 mLife Verify Oral Fluid Drug Test AMP-COC-MET-OPI-PCP-THC-MDMA-OXY |
| G474M3106010 - Classic | 2025-06-30 mLife Classic 6 Panel Oral Fluid Drug Test AMP-COC-MET-OPI-PCP-THC |
| G474M3105010 - Classic | 2025-06-27 mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-PCP |
| G474MC002080001EI0 - Classic | 2025-03-27 mLife Classic 8 Panel Oral Fluid Drug Test AMP-COC-MET-OPI-OXY-BAR-BZO-MDMA |
| G474MC001050002EI0 - Classic | 2024-11-13 mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-THC |
| G474MV002110001EI0 - Verify | 2024-10-16 mLife Verify 11 Panel Oral Fluid Drug Test FYL AMP COC MET OPI THC BAR BZO MDMA OXY PCP |
| G474MV002090004EI0 - Verify | 2024-09-18 mLife Verify 9 Panel Oral Fluid Drug Test AMP BAR BZO COC MDMA MET MTD OPI OXY |