FDA device listing
eCup+ Drug Screening Device (REF 94615),SEFRIA™ Benzoylecgonine Oral Fluid 100 mL Kit,SEFRIA™ Benzoylecgonine Oral Fluid…
FDA device listing 1921907931 · ABBOTT LABORATORIES
Key facts
| Proprietary names | eCup+ Drug Screening Device (REF 94615),SEFRIA™ Benzoylecgonine Oral Fluid 100 mL Kit,SEFRIA™ Benzoylecgonine Oral Fluid 500 mL Kit |
|---|---|
| Owner/operator | ABBOTT LABORATORIES |
| Owner/operator number | 1415939 |
| Product codes | PVA |
| Device names | PVA - Test, Cocaine And Cocaine Metabolite, Employment And Insurance Testing, Exempt |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.3250 |
| Review panels | Clinical Toxicology |
| Registered establishments | Alere San Diego, Inc., Ameditech, Inc. |
| Establishment registrations | 2020952, 2032598 |
| FEI numbers | 2020952, 3003789989 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database