| Healgen® URS Test Strips (K251800) | Healgen Scientific,, LLC | 2025-12-23 |
| AllTest Urinary Tract Infection Test (K252607) | Hangzhou AllTest Biotech Co., Ltd. | 2025-10-30 |
| Safecare Urinary Tract Infection Test (K242767) | Safecare Biotech (Hangzhou) Co., Ltd. | 2025-01-10 |
| Scanostics UTI Check Application Test System (K170118) | Teco Diagnostics | 2017-09-21 |
| TECO DIAGNOSTICS UTI DETECTION STRIPS (K100024) | Teco Diagnostics | 2011-02-17 |
| URINALYSIS REAGENT STRIPS (10 PARAMETERS) (K993850) | International Newtech Development, Inc. | 2000-01-03 |
| DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE (K990873) | Ameritek, Inc. | 1999-09-01 |
| URITEST - NITRITE IN URINE TEST (K954685) | Tcpi, Inc. | 1996-07-22 |
| CHEK-STIX U.T.I. SELF-TEST (K960888) | Bayer Corp. | 1996-07-05 |
| FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS (K953672) | Polymer Technology Intl. | 1996-07-01 |
| BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS (K875248) | Bioscan Instruments, Inc. | 1988-02-24 |
| BIOTEL (TM)/UTI (K855238) | American Diagnostic Corp. | 1986-05-09 |
| KYOTEST 8V (K840828) | Kyoto Diagnostics, Inc. | 1984-05-14 |