Kit, Screening, Urine
FDA product code JXA · Class I (low risk) · 21 CFR 866.2660 · Microbiology
44510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Clinical Convenience Products, Inc. 4
- Izon Business Products, Inc. 3
- Los Alamos Diagnostics 3
- Applied Polytechnology, Inc. 3
- Marion Laboratories, Inc. 2
- Abbott Laboratories 1
- E-Z-Em, Inc. 1
- Pharma-Medica of Scandinavia, Ltd. 1
- Lumac 1
- Analytical Luminescence Laboratory, Inc. 1
- Miles Laboratories, Inc. 1
- Granite Diagnostics, Inc. 1
- Turner Designs, Inc. 1
- Ortho Diagnostic Systems, Inc. 1
- Biotron , Ltd. 1
- Difco Laboratories, Inc. 1
- Syn-Kit, Inc. 1
- New Horizons Diagnostics Co. 1
- Diagnostic Culture System 1
- Osmetech, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011043 | Osmetech Microbial Analyser-Urinary Tract Infection Detector (Oma-Uti)JXA · Traditional | Osmetech | 11/30/2001SE |
| K981084 | UriscreenJXA · Traditional | Diatech Diagnostics,Inc. | 10/07/1998SE |
| K972676 | Urine Screening DeviceJXA · Traditional | Combact Diagnostic Systems , Ltd. | 02/23/1998SE |
| K952246 | Tri-Techin. Custom Blood And/Or Urine Transport KitJXA · Traditional | Tri-Tech, Inc. | 06/20/1995SE |
| K950257 | Multiple (Izon DBS & Urine Collection Kit)JXA · Traditional | Izon Business Products, Inc. | 04/14/1995SE |
| K950246 | Multiple (Izon Urine Collection Kit)JXA · Traditional | Izon Business Products, Inc. | 03/21/1995SESK |
| K950221 | Multiple (Izon Blood & Urine Collection Kit)JXA · Traditional | Izon Business Products, Inc. | 03/21/1995SEKD |
| K934759 | Culturia Macconkey-MugJXA · Traditional | Clinical Convenience Products, Inc. | 09/09/1994SE |
| K924218 | Bac-T-ScreenJXA · Traditional | Biomerieux Vitek, Inc. | 02/03/1993SE |
| K921045 | Diaslide Urine Culturing DeviceJXA · Traditional | Savyon Diagnostics , Ltd. | 09/28/1992SE |
| K911846 | Uri-Three(Tm), ModificationJXA · Traditional | Culture Kits, Inc. | 10/04/1991SE |
| K903470 | QualtureJXA · Traditional | Future Medical Technologies Intl., Inc. | 12/13/1990SE |
| K894805 | Rapidec UrJXA · Traditional | Dms Products, Inc. | 09/26/1989SE |
| K892216 | Gen-Probe Pace System Urine ScreenJXA · Traditional | Gen-Probe, Inc. | 09/15/1989SE |
| K882211 | UriscreenJXA · Traditional | Diatech Diagnostica , Ltd. | 09/30/1988SE |
| K883385 | Resubmitted Utiscreen(Tm) Bacterial Atp TestJXA · Traditional | Los Alamos Diagnostics | 09/07/1988SE |
| K881439 | Modified Utiscreen(Tm) Bacterial Atp Test SystemJXA · Traditional | Los Alamos Diagnostics | 04/28/1988SE |
| K873086 | Round 1JXA · Traditional | Bioclinical Systems, Inc. | 08/24/1987SE |
| K870731 | Lyfo Kwik(Tm) Rus KitJXA · Traditional | Micro-Bio-Logics | 06/17/1987SE |
| K864177 | N-D Urine Tube System (N-D Tube/Cap/Pipette)JXA · Traditional | Cls Co. | 02/24/1987SE |
| K864202 | Utiscreen(R) Bacterial Atp TestJXA · Traditional | Los Alamos Diagnostics | 02/13/1987SE |
| K862195 | Rapid Bacteriuria Screen (RBS)JXA · Traditional | New Horizons Diagnostics Co. | 06/30/1986SE |
| K861631 | Slide Culture U 'Eiken'JXA · Traditional | Syn-Kit, Inc. | 06/10/1986SE |
| K860905 | UricheckJXA · Traditional | Difco Laboratories, Inc. | 04/04/1986SE |
| K860483 | Filtra-Check-UtiJXA · Traditional | Applied Polytechnology, Inc. | 04/04/1986SE |
| K851399 | Bac-T-ScreenJXA · Traditional | Marion Laboratories, Inc. | 06/04/1985SE |
| K843834 | Bacteriuria Detect. Device Aptek IIJXA · Traditional | Applied Polytechnology, Inc. | 11/29/1984SE |
| K843833 | Bacteriuria Detect Device, Multi SamplerJXA · Traditional | Applied Polytechnology, Inc. | 11/29/1984SE |
| K833834 | Ortho Bacteriuria Detection SysJXA · Traditional | Ortho Diagnostic Systems, Inc. | 03/12/1984SE |
| K832975 | Bacterueria Screening ProcedureJXA · Traditional | Turner Designs, Inc. | 11/14/1983SE |
| K830252 | Dipchex Dip-Slide Culture SysJXA · Traditional | Granite Diagnostics, Inc. | 03/07/1983SE |
| K823850 | Bac-T-Screen Bacteriuria Detection DevJXA · Traditional | Marion Laboratories, Inc. | 03/01/1983SE |
| K820126 | Rapid Bacteriuria Screening TestJXA · Traditional | Analytical Luminescence Laboratory, Inc. | 01/07/1983SE |
| K810746 | Lumac's Bacteriuria Screening KitJXA · Traditional | Lumac | 07/31/1981SE |
| K800626 | Uri-Dip (R)JXA · Traditional | Pharma-Medica of Scandinavia, Ltd. | 04/24/1980SE |
| K800215 | Culturia Macconkey/Cled #DM87JXA · Traditional | Clinical Convenience Products, Inc. | 02/13/1980SE |
| K792579 | Culturia Macconkey/Columbia CnaJXA · Traditional | Clinical Convenience Products, Inc. | 01/11/1980SE |
| K792284 | Culturia Emb/Columbia Cna W/5% SheepJXA · Traditional | Clinical Convenience Products, Inc. | 12/19/1979SE |
| K781370 | MS-2 Automated Urine Screening SystemJXA · Traditional | Abbott Laboratories | 09/20/1978SE |
| K781536 | Vac-U-Pac Kidney CassetteJXA · Traditional | E-Z-Em, Inc. | 09/14/1978SE |
| K780803 | Till-U-Test, Dip SlideJXA · Traditional | Biotron , Ltd. | 06/06/1978SE |
| K780021 | Urine Screening KitsJXA · Traditional | Diagnostic Culture System | 03/17/1978SE |
| K780109 | Till-U=TestJXA · Traditional | Clinifax Industries, Ltd. | 01/31/1978SE |
| K771672 | Microcult-IdJXA · Traditional | Miles Laboratories, Inc. | 12/09/1977SE |