| Primary Device ID | G474M3106010 |
| NIH Device Record Key | 8e706be3-53fa-438e-b567-0406e413893a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Classic |
| Version Model Number | M310601 |
| 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 | |
| Phone | 833-654-3339 |
| support@mlifedx.com |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G474M3106010 [Primary] |
| 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 | 2025-06-30 |
| Device Publish Date | 2025-06-20 |
| G474MC001050001EI0 | mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-PCP |
| G474MC001100001EI0 | mLife Classic 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC |
| G474MC001060001EI0 | mLife Classic 6 panel oral fluid drug test AMP-COC-MET-OPI-PCP-THC |
| G474MC002110001EI0 | mLife Classic 11 panel oral fluid drug test AMP-BAR-BZO-COC-FYL-MDMA-MET-OPI-OXY-PCP-THC |
| G474MC002100001EI0 | mLife Classic 10 panel oral fluid drug test AMP-BAR-BZO-COC-MDMA-MET-OPI-OXY-PCP-THC |
| G474MC001050002EI0 | mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-THC |
| G474MC002080001EI0 | mLife Classic 8 Panel Oral Fluid Drug Test AMP-COC-MET-OPI-OXY-BAR-BZO-MDMA |
| G474M3105010 | mLife Classic 5 panel oral fluid drug test AMP-COC-MET-OPI-PCP |
| G474M3106010 | mLife Classic 6 Panel Oral Fluid Drug Test AMP-COC-MET-OPI-PCP-THC |