| Primary Device ID | B77880510ODEI0 | 
| NIH Device Record Key | 86e303bd-ea41-48fc-9245-376e4101f607 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Origin Instant Oral Drug Test | 
| Version Model Number | 80510-OD-EI | 
| Catalog Number | 80510-OD-EI | 
| Company DUNS | 036225773 | 
| Company Name | ORIGIN 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 | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | |
| Phone | 1-800-440-6695 | 
| orders@origin.net | 
| 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 | 
| 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 | 
| 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 | B77880510ODEI0 [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 | 2021-01-27 | 
| Device Publish Date | 2021-01-19 | 
| B77881025ODEI0 | Origin Instant Oral Drug Test, AMP-BAR-BUP-BZO-COC-MDMA-MET-OPI-OXY-THC | 
| B77880902ODEI0 | Origin Instant Oral Drug Test, AMP-BUP-BZO-COC-MET-MTD-OPI-OXY-THC | 
| B77880600ODEI0 | Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI-THC | 
| B77880502ODEI0 | Origin Instant Oral Drug Test, AMP-COC-MET-OPI-THC | 
| B77880409ODEI0 | Origin Instant Oral Drug Test, AMP-COC-MET-OPI | 
| B77880510ODEI0 | Origin Instant Oral Drug Test, AMP-BZO-COC-MET-OPI |