Is this your brand? Sign in to claim ownership.
Sign in to claim this brandORIGIN DIAGNOSTICS LLC
US
Last updated May 24, 2026
What ORIGIN DIAGNOSTICS LLC makes
Origin Diagnostics LLC manufactures rapid in vitro diagnostic (IVD) tests for detecting multiple drugs of abuse. These include oral fluid and dipstick formats designed for clinical and point-of-care use, providing results within minutes. The tests are intended for screening purposes in settings such as emergency departments, workplaces, and rehabilitation programs.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. Origin Diagnostics LLC is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Origin Diagnostics LLC manufacture?
Origin Diagnostics LLC specializes in rapid in vitro diagnostic (IVD) tests for detecting multiple drugs of abuse. These tests come in formats like oral fluid swabs and dipstick kits, designed for quick screening in clinical or point-of-care settings, such as emergency rooms, workplaces, or rehabilitation programs. The devices are intended for initial screening, not definitive diagnosis.
Where is Origin Diagnostics LLC based?
Origin Diagnostics LLC is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices, including those governing in vitro diagnostics.
Which regulatory registries list Origin Diagnostics LLC’s devices?
Origin Diagnostics LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify Class II medical devices, ensuring transparency and traceability for healthcare providers and regulators.
How are Origin Diagnostics LLC’s devices classified under FDA regulations?
Origin Diagnostics LLC’s rapid drug-of-abuse tests are classified as Class II medical devices by the FDA. This classification applies because they are moderate-risk devices requiring special controls to ensure their safety and performance, such as validation of test accuracy and clear labeling for screening use only.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- origin.net
- —
- —
- [email protected]
- Phone
- 1-800-440-6695
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 036225773
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Origin Instant Oral Drug Test | 80902-OD-EI | FDA UDI | Class II | Active |
| Origin Instant Oral Drug Test | 80409-OD-EI | FDA UDI | Class II | Active |
| Origin Instant Dip Drug Test | 30940-OD | FDA UDI | Class II | Active |
| Origin Instant Drug Test | 60500-3-OD | FDA UDI | Class II | Active |
| Origin Instant Drug Test | 81026-OD-EI | FDA UDI | Class II | Active |
| Origin Instant Drug Test | 60600-3-OD | FDA UDI | Class II | Active |
| Origin Instant Dip Drug Test | 31016-OD | FDA UDI | Class II | Active |
| Origin Instant Oral Drug Test | 81025-OD-EI | FDA UDI | Class II | Active |
| Origin Instant Drug Test | 60500-OD-OTC | FDA UDI | Class II | Active |
| Origin Instant Dip Drug Test | 30500-OD | FDA UDI | Class II | Active |
| Origin Instant Oral Drug Test | 80600-OD-EI | FDA UDI | Class II | Active |
| Origin Instant Drug Test | 60505-3-OD | FDA UDI | Class II | Active |
| Origin Instant Drug Test | 61007-3-OD | FDA UDI | Class II | Active |
| Origin Instant Drug Test | 61147-3-OD | FDA UDI | Class II | Active |
| Origin Instant Drug Test | 61025-OD | FDA UDI | Class II | Active |
| Origin Instant Dip Drug Test | 31236-OD | FDA UDI | Class II | Active |
| Origin Instant Drug Test | 60440-3-OD | FDA UDI | Class II | Active |
| Origin Instant Drug Test | 61007-OD-OTC | FDA UDI | Class II | Active |
| Origin Instant Oral Drug Test | 80510-OD-EI | FDA UDI | Class II | Active |
| Origin Instant Drug Test | 61013-3-OD | FDA UDI | Class II | Active |
| Origin Instant Oral Drug Test | 80502-OD-EI | FDA UDI | Class II | Active |
| Origin Instant Dip Drug Test | 30573-OD | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.