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Sign in to claim this brandONE STEP DETEX ASSOCIATES
US
Last updated May 24, 2026
What ONE STEP DETEX ASSOCIATES makes
One Step Detex Associates manufactures rapid immunoassay kits for detecting multiple drugs of abuse in clinical and point-of-care settings. These products are designed for immediate, on-site testing of urine samples to identify substances such as opioids, cocaine, amphetamines, and benzodiazepines. The kits are intended for use in emergency departments, detoxification programs, and other healthcare environments requiring quick results. They are formatted as individual test devices or multi-panel assays for comprehensive screening.
The company’s drug testing devices are classified as Class II medical devices under FDA regulations, with some variants falling under Class U (unspecified risk). These products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. regulatory requirements. The manufacturer operates within the United States, adhering to domestic medical device standards and reporting obligations.
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 One Step Detex Associates manufacture?
One Step Detex Associates specializes in rapid immunoassay kits designed for detecting multiple drugs of abuse. These devices are intended for clinical and point-of-care use, such as emergency departments or detoxification programs, and are formatted as individual test devices or multi-panel assays. The focus is on immediate, on-site testing of urine samples to identify substances like opioids, cocaine, amphetamines, and benzodiazepines.
Where is One Step Detex Associates based, and does this affect its regulatory compliance?
One Step Detex Associates is based in the United States. Since its devices are manufactured domestically, they must comply with U.S. medical device regulations, including classification under FDA guidelines and listing in the FDA’s Unique Device Identifier (UDI) database. This ensures traceability and adherence to domestic standards for drug testing products.
How are the devices manufactured by One Step Detex Associates classified under FDA regulations?
The devices produced by One Step Detex Associates are classified primarily as Class II medical devices under FDA regulations. This classification applies to products with moderate risk, where general controls alone are insufficient, and special controls are required to ensure safety and effectiveness. Some variants may also fall under Class U (unspecified risk), indicating they do not meet the criteria for Class I or Class II but still require regulatory oversight.
Which regulatory registries or databases list the devices made by One Step Detex Associates?
The devices manufactured by One Step Detex Associates are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each device can be traced, tracked, and verified for compliance with U.S. regulatory requirements, supporting transparency and accountability in the medical device supply chain.
Why are the drug testing kits from One Step Detex Associates designed for rapid testing?
The rapid immunoassay kits from One Step Detex Associates are designed for immediate, on-site testing to provide quick results in clinical or point-of-care settings. This is particularly important in environments like emergency departments or detoxification programs, where timely identification of drugs of abuse can inform patient care decisions, treatment planning, or compliance monitoring without delays.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- (888)822-7120
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 044096902
Catalogue (28)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dtx® | DOA-164-1201 | FDA UDI | Class II | Active |
| Dtx® | DBZ-114 | FDA UDI | Class II | Active |
| Dtx® | DMA-114 | FDA UDI | Class II | Active |
| Dtx® | DMD-114 | FDA UDI | Class II | Active |
| Dtx® | DOA-1145 | FDA UDI | Class II | Unknown |
| Dtx® | DOA-2167 | FDA UDI | Class II | Unknown |
| Dtx® | DOX-114 | FDA UDI | Class II | Active |
| Dtx® | DBA-114 | FDA UDI | Class II | Active |
| Dtx® | DOA-124 | FDA UDI | Class II | Active |
| Dtx® | DOA-264 | FDA UDI | Class II | Active |
| Dtx® | DOA-2165 | FDA UDI | Class II | Active |
| Dtx® | DOA-154 | FDA UDI | Class II | Unknown |
| Dtx® | DOA-184 | FDA UDI | Class II | Unknown |
| Dtx® | DOA-144 | FDA UDI | Class II | Active |
| Dtx® | DOA-134 | FDA UDI | Class II | Active |
| Dtx® | DOA-954 | FDA UDI | Class II | Active |
| Dtx® | DOA-144-851 | FDA UDI | Class II | Active |
| Dtx® | DOA-1127-061 | FDA UDI | Class II | Active |
| Dtx® | DBU-114 | FDA UDI | Class II | Active |
| Dtx® | DCO-114 | FDA UDI | Class II | Active |
| Dtx® | DPC-114 | FDA UDI | U | Active |
| Dtx® | DMT-114 | FDA UDI | Class II | Active |
| Dtx® | DAM-114 | FDA UDI | Class II | Active |
| Dtx® | DOA-1104 | FDA UDI | Class II | Unknown |
| Dtx® | DOA-1257 | FDA UDI | Class II | Active |
| Dtx® | DOP-114 | FDA UDI | Class II | Active |
| Dtx® | DTH-114 | FDA UDI | Class II | Active |
| Dtx® | DOA-197-141 | FDA UDI | Class II | Active |
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