Product code JXA
- Device name
- Kit, Screening, Urine
- Medical specialty
- Microbiology
- Device class
- 1
- Regulation number
- 866.2660
- Review panel
- MI
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011043 | OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) | Osmetech | 2001-11-30 |
| K981084 | URISCREEN | Diatech Diagnostics,Inc. | 1998-10-07 |
| K972676 | URINE SCREENING DEVICE | Combact Diagnostic Systems , Ltd. | 1998-02-23 |
| K952246 | TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT | Tri-Tech, Inc. | 1995-06-20 |
| K950257 | MULTIPLE (IZON DBS & URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-04-14 |
| K950246 | MULTIPLE (IZON URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-03-21 |
| K950221 | MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) | Izon Business Products, Inc. | 1995-03-21 |
| K934759 | CULTURIA MACCONKEY-MUG | Clinical Convenience Products, Inc. | 1994-09-09 |
| K924218 | BAC-T-SCREEN | Biomerieux Vitek, Inc. | 1993-02-03 |
| K921045 | DIASLIDE URINE CULTURING DEVICE | Savyon Diagnostics , Ltd. | 1992-09-28 |
| K911846 | URI-THREE(TM), MODIFICATION | Culture Kits, Inc. | 1991-10-04 |
| K903470 | QUALTURE | Future Medical Technologies Intl., Inc. | 1990-12-13 |
| K894805 | RAPIDEC UR | Dms Products, Inc. | 1989-09-26 |
| K892216 | GEN-PROBE PACE SYSTEM URINE SCREEN | Gen-Probe, Inc. | 1989-09-15 |
| K882211 | URISCREEN | Diatech Diagnostica , Ltd. | 1988-09-30 |
| K883385 | RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST | Los Alamos Diagnostics | 1988-09-07 |
| K881439 | MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM | Los Alamos Diagnostics | 1988-04-28 |
| K873086 | ROUND 1 | Bioclinical Systems, Inc. | 1987-08-24 |
| K870731 | LYFO KWIK(TM) RUS KIT | Micro-Bio-Logics | 1987-06-17 |
| K864177 | N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE) | Cls Co. | 1987-02-24 |
| K864202 | UTISCREEN(R) BACTERIAL ATP TEST | Los Alamos Diagnostics | 1987-02-13 |
| K862195 | RAPID BACTERIURIA SCREEN (RBS) | New Horizons Diagnostics Co. | 1986-06-30 |
| K861631 | SLIDE CULTURE U 'EIKEN' | Syn-Kit, Inc. | 1986-06-10 |
| K860483 | FILTRA-CHECK-UTI | Applied Polytechnology, Inc. | 1986-04-04 |
| K860905 | URICHECK | Difco Laboratories, Inc. | 1986-04-04 |
| K851399 | BAC-T-SCREEN | Marion Laboratories, Inc. | 1985-06-04 |
| K843834 | BACTERIURIA DETECT. DEVICE APTEK II | Applied Polytechnology, Inc. | 1984-11-29 |
| K843833 | BACTERIURIA DETECT DEVICE, MULTI SAMPLER | Applied Polytechnology, Inc. | 1984-11-29 |
| K833834 | ORTHO BACTERIURIA DETECTION SYS | Ortho Diagnostic Systems, Inc. | 1984-03-12 |
| K832975 | BACTERUERIA SCREENING PROCEDURE | Turner Designs, Inc. | 1983-11-14 |
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|---|---|---|---|
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| 07290013348531 | URISCREEN | SAVYON DIAGNOSTICS LTD | 2026-04-29 |
| 50885380070271 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2024-02-28 |
| 00860008737359 | Know Rapid STD Test | MobiLab Medical Innovatives Inc. | 2024-02-06 |
| 00860008737304 | MobiLab Standard Sexual Health Self Rapid Test | MobiLab Medical Innovatives Inc. | 2024-02-05 |
| 00613647003657 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 20613647003590 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 20613647003606 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647003718 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647003701 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647003664 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647003640 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647003633 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647003626 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647003619 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647003602 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 00613647003596 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 20613647003613 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 20613647003620 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 20613647003637 | Fisherbrand | FISHER SCIENTIFIC COMPANY L.L.C. | 2022-12-07 |
| 03573026600402 | CHROMID® CPS® Elite Agar (CPSO) | BIOMERIEUX SA | 2020-05-19 |
| 03573026468545 | CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood | BIOMERIEUX SA | 2020-05-19 |
| 03573026468170 | CHROMID® CPS® Elite Agar (CPSO) | BIOMERIEUX SA | 2020-05-19 |
| 03573026443900 | CHROMID® CPS® Elite Agar (CPSE) | BIOMERIEUX SA | 2020-05-19 |
| 03573026600426 | CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood | BIOMERIEUX SA | 2020-05-19 |
| 03573026600389 | CHROMID® CPS® Elite Agar (CPSE) | BIOMERIEUX SA | 2020-05-19 |
| 10885380068553 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-05-15 |
| 10885380068560 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-05-01 |
| 30885380069301 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-04-29 |
| 20885380068529 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2019-04-29 |