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| Product | Model | Company | Device type |
|---|---|---|---|
| AIMSTRIP URINE AUTO ANALYZERGermaine Laboratories, IncUrine analyser IVD, laboratory | 51110 | Germaine Laboratories, Inc | Urine analyser IVD, laboratory |
| AIMSTRIP US-5BGermaine Laboratories, IncMultiple urine analyte IVD, kit, rapid colorimetric, clinical | 55200 | Germaine Laboratories, Inc | Multiple urine analyte IVD, kit, rapid colorimetric, clinical |
| AIMSTRIP US-GGermaine Laboratories, IncUrine glucose IVD, kit, rapid colorimetric, clinical | 50100 | Germaine Laboratories, Inc | Urine glucose IVD, kit, rapid colorimetric, clinical |
| Alltest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.Urine leukocyte IVD, kit, rapid colorimetric, clinical | 1 | Hangzhou AllTest Biotech Co., Ltd. | Urine leukocyte IVD, kit, rapid colorimetric, clinical |
| AUTION EYE™ AI-4510 AnalyzerArkray USA, Inc.Urine analyser IVD, laboratory | 108861 | Arkray USA, Inc. | Urine analyser IVD, laboratory |
| CYBOW PDfi Co.,ltdMultiple urine analyte IVD, kit, rapid colorimetric, clinical | 0143 | Dfi Co.,ltd | Multiple urine analyte IVD, kit, rapid colorimetric, clinical |
| DG HealthReese Pharmaceutical CompanyMultiple urine analyte IVD, kit, rapid colorimetric, clinical | UTES | Reese Pharmaceutical Company | Multiple urine analyte IVD, kit, rapid colorimetric, clinical |
| DRI pH DetectMicrogenics CorporationUrine pH IVD, kit, rapid colorimetric, clinical | 100054 | Microgenics Corporation | Urine pH IVD, kit, rapid colorimetric, clinical |
| DRI pH-Detect pH 11.5 Control KitMicrogenics CorporationUrine pH IVD, kit, rapid colorimetric, clinical | 100281 | Microgenics Corporation | Urine pH IVD, kit, rapid colorimetric, clinical |
| DxUBeckman Coulter, Inc.Urine analyser IVD, laboratory | D38581 | Beckman Coulter, Inc. | Urine analyser IVD, laboratory |
| Easy@Home Urinary Tract Infection Test Strips (10 Pack)Easy Healthcare CorporationMultiple urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) | EZU-101 | Easy Healthcare Corporation | Multiple urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT) |
| Exploro Vaginal Health pH Test DeviceSafecare Biotech (Hangzhou) Co., Ltd.Vaginal pH screening IVD, kit, rapid colorimetric, clinical | 7 Tests | Safecare Biotech (Hangzhou) Co., Ltd. | Vaginal pH screening IVD, kit, rapid colorimetric, clinical |
| Hemastix® Reagent StripsSiemens Healthcare Diagnostics Inc.Urine blood IVD, kit, rapid colorimetric, clinical | 10312568 | Siemens Healthcare Diagnostics Inc. | Urine blood IVD, kit, rapid colorimetric, clinical |
| ICTOTEST® Reagent Tablets and Mats for UrinalysisSiemens Healthcare Diagnostics Inc.Urine bilirubin IVD, kit, rapid colorimetric, clinical | 10337316 | Siemens Healthcare Diagnostics Inc. | Urine bilirubin IVD, kit, rapid colorimetric, clinical |
| InstaTestDiagnostic Automation, Inc.Multiple urine analyte IVD, kit, rapid colorimetric, clinical | DACDURS-1P (100) | Diagnostic Automation, Inc. | Multiple urine analyte IVD, kit, rapid colorimetric, clinical |
| LEUCINE ARYLAMIDASE (LAP)Randox Laboratories LimitedOxytocinase IVD, kit, rapid colorimetric, clinical | LA561 | Randox Laboratories Limited | Oxytocinase IVD, kit, rapid colorimetric, clinical |
| MetricJilin Test BIO-Electron Co.,LtdMultiple urine analyte IVD, kit, rapid colorimetric, clinical | 50pcs/bottle | Jilin Test BIO-Electron Co.,Ltd | Multiple urine analyte IVD, kit, rapid colorimetric, clinical |
| MISSION U500 URINE ANALYZERAcon Laboratories, Inc.Urine analyser IVD, point-of-care | U211-101 | Acon Laboratories, Inc. | Urine analyser IVD, point-of-care |
| Mission Urinalysis Reagent StripsAcon Laboratories, Inc.Multiple urine analyte IVD, kit, rapid colorimetric, clinical | U031-021 | Acon Laboratories, Inc. | Multiple urine analyte IVD, kit, rapid colorimetric, clinical |
| Mission Urinalysis Reagent StripsAcon Laboratories, Inc.Multiple urine analyte IVD, kit, rapid colorimetric, clinical | U031-051 | Acon Laboratories, Inc. | Multiple urine analyte IVD, kit, rapid colorimetric, clinical |
| Mission Urinalysis Reagent StripsAcon Laboratories, Inc.Multiple urine analyte IVD, kit, rapid colorimetric, clinical | U031-081 | Acon Laboratories, Inc. | Multiple urine analyte IVD, kit, rapid colorimetric, clinical |
| TECO DIAGNOSTICSTeco DiagnosticsUrine blood IVD, kit, rapid colorimetric, clinical | URS-1B-100 GENERIC | Teco Diagnostics | Urine blood IVD, kit, rapid colorimetric, clinical |
| TECO DIAGNOSTICSTeco DiagnosticsUrine ketone IVD, kit, rapid colorimetric, clinical | URS-1K-50-01 MUSTAFA | Teco Diagnostics | Urine ketone IVD, kit, rapid colorimetric, clinical |
| Uric Acid Test StripUrit Medical Electronic Co., Ltd.Uric acid monitoring system IVD, home-use | PA 11,25strips/vial×2/box | Urit Medical Electronic Co., Ltd. | Uric acid monitoring system IVD, home-use |
| Uric Acid Test StripUrit Medical Electronic Co., Ltd.Uric acid monitoring system IVD, home-use | URIT U10,10strips/vial | Urit Medical Electronic Co., Ltd. | Uric acid monitoring system IVD, home-use |