JXA · Kit, Screening, Urine
Microbiology · 21 CFR 866.2660 · Class 1
Overview
| Product Code | JXA |
|---|---|
| Device Name | Kit, Screening, Urine |
| Regulation | 21 CFR 866.2660 |
| Device Class | Class 1 |
| Review Panel | Microbiology |
Identification
A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
Recent Cleared Devices (20 of 44)
Showing 20 most recent of 44 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K011043 | OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) | Osmetech | Nov 30, 2001 | SESE |
| K981084 | URISCREEN | Diatech Diagnostics,Inc. | Oct 7, 1998 | SESE |
| K972676 | URINE SCREENING DEVICE | Combact Diagnostic Systems , Ltd. | Feb 23, 1998 | SESE |
| K952246 | TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT | Tri-Tech, Inc. | Jun 20, 1995 | SESE |
| K950257 | MULTIPLE (IZON DBS & URINE COLLECTION KIT) | Izon Business Products, Inc. | Apr 14, 1995 | SESE |
| K950246 | MULTIPLE (IZON URINE COLLECTION KIT) | Izon Business Products, Inc. | Mar 21, 1995 | SESK |
| K950221 | MULTIPLE (IZON BLOOD & URINE COLLECTION KIT) | Izon Business Products, Inc. | Mar 21, 1995 | SEKD |
| K934759 | CULTURIA MACCONKEY-MUG | Clinical Convenience Products, Inc. | Sep 9, 1994 | SESE |
| K924218 | BAC-T-SCREEN | Biomerieux Vitek, Inc. | Feb 3, 1993 | SESE |
| K921045 | DIASLIDE URINE CULTURING DEVICE | Savyon Diagnostics , Ltd. | Sep 28, 1992 | SESE |
| K911846 | URI-THREE(TM), MODIFICATION | Culture Kits, Inc. | Oct 4, 1991 | SESE |
| K903470 | QUALTURE | Future Medical Technologies Intl., Inc. | Dec 13, 1990 | SESE |
| K894805 | RAPIDEC UR | Dms Products, Inc. | Sep 26, 1989 | SESE |
| K892216 | GEN-PROBE PACE SYSTEM URINE SCREEN | Gen-Probe, Inc. | Sep 15, 1989 | SESE |
| K882211 | URISCREEN | Diatech Diagnostica , Ltd. | Sep 30, 1988 | SESE |
| K883385 | RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST | Los Alamos Diagnostics | Sep 7, 1988 | SESE |
| K881439 | MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM | Los Alamos Diagnostics | Apr 28, 1988 | SESE |
| K873086 | ROUND 1 | Bioclinical Systems, Inc. | Aug 24, 1987 | SESE |
| K870731 | LYFO KWIK(TM) RUS KIT | Micro-Bio-Logics | Jun 17, 1987 | SESE |
| K864177 | N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE) | Cls Co. | Feb 24, 1987 | SESE |
Top Applicants
- Clinical Convenience Products, Inc. — 4 clearances
- Applied Polytechnology, Inc. — 3 clearances
- Izon Business Products, Inc. — 3 clearances
- Los Alamos Diagnostics — 3 clearances
- Marion Laboratories, Inc. — 2 clearances
