FDA device listing
easy@Home Urinary Tract Infection Test,HealthyMe Urinary Tract Infection Test Strips,Mission UTI Urinary Tract Infection…
FDA device listing 1162562000 · ACON Laboratories, Inc.
Key facts
| Proprietary names | easy@Home Urinary Tract Infection Test,HealthyMe Urinary Tract Infection Test Strips,Mission UTI Urinary Tract Infection Test Strips,Test Yourself @ Home Urinary Tract Infection Test Strips,Urinox Urinary Tract Infection Test Strips,Vivoo At-Home Urinary Tract Infection Test |
|---|---|
| Owner/operator | ACON Laboratories, Inc. |
| Owner/operator number | 9063887 |
| Premarket submissions | K063295 |
| Product codes | JMT, LJX |
| Device names | JMT - Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), LJX - Test, Urine Leukocyte |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.1510, 864.7675 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | ACON LABORATORIES, INC. |
| Establishment registrations | 2531491 |
| FEI numbers | 3003516723 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 10–99 Device listings citing the same submission
- Yes 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