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Sign in to claim this brandLifesign L.L.C.
US
Last updated May 30, 2026
What Lifesign L.L.C. makes
Lifesign L.L.C. manufactures in vitro diagnostic (IVD) devices for detecting drugs of abuse and screening for adulteration in clinical settings. Their products include rapid immunoassay kits and spectrophotometry-based tests, designed for point-of-care use in identifying substances such as drugs and potential adulterants in urine samples.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for clinical and forensic applications, ensuring compliance with U.S. medical device standards.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- lifesignmed.com
- —
- —
- [email protected]
- Phone
- 1-800-526-2125
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 010964864
Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Status Toxi Cup 13+4 | 65C12+4 | FDA UDI | Class II | Unknown |
| LifeSign QuikScreen 11 | 60B02 | FDA UDI | Class II | Unknown |
| Status ASSURE | 11125AA2K | FDA UDI | Class II | Active |
| Status ASSURE | 71125AA2K | FDA UDI | Class II | Active |
| Status ASSURE | 11125AA | FDA UDI | Class II | Active |
| Status ASSURE | 76025AA2K | FDA UDI | Class II | Active |
| Status ASSURE | 71125AA | FDA UDI | Class II | Active |
| Status Toxi Cup | 65C13+4 | FDA UDI | Class II | Active |
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