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Sign in to claim this brandAMERICAN SCREENING, L.L.C.
US
Last updated May 23, 2026
What AMERICAN SCREENING, L.L.C. makes
American Screening, LLC produces in vitro diagnostic (IVD) devices for detecting multiple drugs of abuse, including rapid immunoassay test kits and clinical testing systems. These products are designed for point-of-care and laboratory use to identify substances such as opioids, cocaine, benzodiazepines, and other controlled substances in human samples. The portfolio includes both single-use and multi-use formats for testing urine, oral fluid, and other biological specimens. Examples include rapid test kits like OneScreen and Discover, as well as clinical-grade systems such as Precision DX and Discover Plus.
The company’s devices are classified under FDA’s Class II and Unclassified (U) regulatory categories, with all products listed in the FDA’s Unique Device Identifier (UDI) database. These classifications apply to diagnostic tests intended for detecting drugs of abuse in regulated medical settings. The manufacturer operates from the United States, adhering to applicable FDA requirements for IVD device compliance and traceability.
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 American Screening, LLC manufacture?
American Screening, LLC specializes in in vitro diagnostic (IVD) devices focused on detecting multiple drugs of abuse. Their portfolio includes rapid immunoassay test kits (such as OneScreen and Discover) for point-of-care use, as well as clinical-grade systems (like Precision DX and Discover Plus) designed for laboratory testing. These devices are intended for identifying substances like opioids, cocaine, and benzodiazepines in biological samples such as urine or oral fluid.
Where is American Screening, LLC based, and what regulatory framework does it follow?
American Screening, LLC is based in the United States. Its devices are developed in compliance with FDA requirements for in vitro diagnostics, including regulatory classifications and traceability standards. Since these products are classified under FDA’s Class II and Unclassified (U) categories, they must meet specific performance and safety criteria for drug-of-abuse testing in regulated medical settings.
Are American Screening, LLC’s devices listed in any regulatory registries?
Yes, American Screening, LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II and Unclassified (U) diagnostic tests, particularly those used for detecting drugs of abuse in clinical or point-of-care environments. Listing in the UDI database is a requirement for FDA-compliant IVD devices.
How are American Screening, LLC’s drug-of-abuse testing devices classified by the FDA?
American Screening, LLC’s devices fall under the FDA’s Class II and Unclassified (U) regulatory classifications. Class II devices typically require special controls to ensure their safety and effectiveness, while Unclassified (U) devices may involve lower-risk diagnostic tests that still require compliance with FDA guidelines. These classifications apply because the devices are intended for detecting drugs of abuse in controlled medical settings, where accuracy and reliability are critical.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 169065054
Catalogue (1499)
Page 10 of 30| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Precision DX | PREDX-DOA5114N | FDA UDI | Class II | Active |
| Precision | PRENQ-COT-S23 | FDA UDI | Class II | Active |
| Precision DX | PREDX-CUP1284N | FDA UDI | Class II | Active |
| Discover | DIS-DPP-114 | FDA UDI | Class II | Active |
| Precision DX | PREDX-DOA-654N | FDA UDI | Class II | Active |
| Precision DX | PREDX-CUP2125N | FDA UDI | U | Active |
| OneScreen | ASC-DED-114 | FDA UDI | Class II | Active |
| Precision DX | PREDX-CUP8174N | FDA UDI | Class II | Active |
| Discover | DIS-DOA-394 | FDA UDI | Class II | Active |
| Discover Plus | DISP-DOA655NPT | FDA UDI | Class II | Active |
| Discover Plus | DISPDOA15104NC | FDA UDI | Class II | Active |
| Discover Plus | DISPDUD25124ND | FDA UDI | Class II | Active |
| Discover Plus | DISP-DOA1554SP | FDA UDI | Class II | Active |
| Precision DX | PREDX-DOA7125N | FDA UDI | Class II | Active |
| Precision DX | PREDX-DOA9124N | FDA UDI | Class II | Active |
| Discover | ASC-OSAL-264 | FDA UDI | Class II | Active |
| Precision DX | PREDX-CUP9174N | FDA UDI | U | Active |
| Discover Plus | DISP-DTH15-114 | FDA UDI | Class II | Active |
| 00840050508268 | DISP-DOA434NPT | FDA UDI | Class II | Active |
| Precision Plus | PREPL-DUD8136N | FDA UDI | Class II | Active |
| Discover | DIS-DOA-7104GO | FDA UDI | Class II | Active |
| Precision DX | PREDX-MD-U410 | FDA UDI | Class II | Active |
| Discover Plus | DISP-DOA-274N | FDA UDI | Class II | Active |
| Precision Plus | PREPLCUP40124N | FDA UDI | U | Active |
| Precision DX | PREDX-DOA1174N | FDA UDI | Class II | Active |
| Discover | DIS-KCUP-154 | FDA UDI | Class II | Active |
| Precision DX | PREDX-DOA-164N | FDA UDI | Class II | Active |
| Reveal | ASC-RDUD2144N | FDA UDI | Class II | Active |
| Discover | ASC-SAL-664 | FDA UDI | Class II | Active |
| Discover | ASC-SAL-164 | FDA UDI | Class II | Active |
| Precision DX | PREDX-DTH-114N | FDA UDI | Class II | Active |
| OneScreen | ASC-DOA-184 | FDA UDI | Class II | Active |
| Discover | DIS-SAL-254 | FDA UDI | Class II | Active |
| Discover | ASC-SAL-164 | FDA UDI | Class II | Active |
| OneScreen | ASC-DOA-7104 | FDA UDI | Class II | Active |
| Precision DX | PREDX-DOA1374N | FDA UDI | Class II | Active |
| Precision DX | PREDX-DOA-9104 | FDA UDI | Class II | Active |
| Precision DX | PREDX-DOP-114N | FDA UDI | U | Active |
| Precision DX | PREDX-CUP-374N | FDA UDI | Class II | Active |
| Reveal | ASC-RCUP-2354 | FDA UDI | Class II | Active |
| OneScreen | ASC-CUP-254 | FDA UDI | Class II | Active |
| Precision DX | PREDXCUP2174BL | FDA UDI | Class II | Active |
| OneScreen | ASC-DMO-114 | FDA UDI | Class II | Active |
| Precision DX | PREDX-DUD2134N | FDA UDI | Class II | Active |
| OneScreen | ASCDUD-394AYVA | FDA UDI | Class II | Active |
| Discover | DIS-DUD20104SP | FDA UDI | Class II | Active |
| Precision DX | PREDXOSAL17123 | FDA UDI | Class II | Active |
| Discover | DIS-DTC-114 | FDA UDI | Class II | Active |
| OneScreen | ASC-DOA-744X | FDA UDI | Class II | Active |
| OneScreen | ASC-DOA-264 | FDA UDI | Class II | Active |
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