Acid, Uric, Uricase (U.V.)
FDA product code CDO · Class I (low risk) · 21 CFR 862.1775 · Clinical Chemistry
31510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Em Diagnostic Systems, Inc. 4
- Abbott Laboratories 2
- Sigma Diagnostics, Inc. 2
- Emd Chemicals, Inc. 2
- Worthington Biochemical Corp. 2
- Biorent Diagnostic, Inc. 1
- Biotrol, USA, Inc. 1
- Electro-Nucleonics Laboratories, Inc. 1
- Randox Laboratories, Ltd. 1
- Technicon Instruments Corp. 1
- Harleco Diagnostics 1
- Syn-Kit, Inc. 1
- Harleco 1
- Boehringer Mannheim Corp. 1
- Roche Analytical Instruments, Inc. 1
- Union Carbide Corp. 1
- The Dow Chemical Co. 1
- Calbiochem-Behring Corp. 1
- Bd Becton Dickinson Vacutainer Systems Preanalytic 1
- Instrumentation Laboratory CO 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K033278 | Randox Uric AcidCDO · Traditional | Randox Laboratories, Ltd. | 02/27/2004SE |
| K992798 | Sigma Diagnostics Infinity Uric Acid Reagent, Models 684-25, 684-100P, 684-500P…CDO · Traditional | Sigma Diagnostics, Inc. | 09/28/1999SE |
| K982251 | Sigma Diagnostics Infinity Uric Acid Reagent KitCDO · Traditional | Sigma Diagnostics, Inc. | 08/18/1998SE |
| K981766 | Uric AcidCDO · Traditional | Abbott Laboratories | 06/19/1998SE |
| K981189 | Uric AcidCDO · Traditional | Abbott Laboratories | 05/07/1998SE |
| K971485 | Uric Acid - Incorporating Dynamic Stabilization Technology - (DST)CDO · Traditional | Trace America, Inc. | 05/27/1997SE |
| K955752 | Olympus Uric Acid ReagentCDO · Traditional | Olympus America, Inc. | 01/31/1996SE |
| K932162 | Uric Acid Test Item Number 65422CDO · Traditional | Em Diagnostic Systems, Inc. | 09/27/1993SE |
| K923765 | Systemate Uricacid Test, Technicon Ra 1000CDO · Traditional | Em Diagnostic Systems, Inc. | 09/22/1992SE |
| K903335 | Systemate Uric Acid (Urca) Item Number 65422CDO · Traditional | Em Diagnostic Systems, Inc. | 08/17/1990SE |
| K875320 | Biotrol Uric Acid Enzymatique UV H.P.CDO · Traditional | Biotrol, USA, Inc. | 02/01/1988SE |
| K873358 | Gemeni Uric Acid U.V.CDO · Traditional | Electro-Nucleonics Laboratories, Inc. | 09/11/1987SE |
| K863660 | Emds Uric Acid (Urc a) Testpack, Item #67664/95CDO · Traditional | Em Diagnostic Systems, Inc. | 10/29/1986SE |
| K844986 | Roche Reagents Reagent for Uric AcidCDO · Traditional | Roche Diagnostic Systems, Inc. | 01/18/1985SE |
| K822884 | Uric Acid 75CDOCDO · Traditional | Technicon Instruments Corp. | 10/27/1982SE |
| K821872 | Ultrachem Uric Acid AidhCDO · Traditional | Harleco Diagnostics | 07/14/1982SE |
| K821474 | Ultrachem Uric Acid Aidh #65047CDO · Traditional | Emd Chemicals, Inc. | 06/03/1982SE |
| K821465 | Ultrachem Uric Acid Aidh, #65047CDO · Traditional | Emd Chemicals, Inc. | 06/02/1982SE |
| K821167 | Uricase (U.V.) Uric AcidCDO · Traditional | Syn-Kit, Inc. | 05/14/1982SE |
| K813244 | UV Uric Acid DeterminationCDO · Traditional | Biorent Diagnostic, Inc. | 12/08/1981SE |
| K812500 | Ultrachem Uric Acid Aldh, Item #65047CDO · Traditional | Harleco | 09/23/1981SE |
| K802371 | Uric Acid/AldhCDO · Traditional | Boehringer Mannheim Corp. | 10/23/1980SE |
| K801243 | Cobas Reagents for Uric AcidCDO · Traditional | Roche Analytical Instruments, Inc. | 06/26/1980SE |
| K800130 | Centrifichem Uric AcidCDO · Traditional | Union Carbide Corp. | 02/13/1980SE |
| K790834 | UV Uric Acid DeterminationCDO · Traditional | The Dow Chemical Co. | 06/28/1979SE |
| K781996 | Acid Reagent, Uric Single VialCDO · Traditional | Calbiochem-Behring Corp. | 01/03/1979SE |
| K780859 | Princeton Biomedix Uricase (UV)CDO · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 07/27/1978SE |
| K771509 | Multistat III Uric Acid TestCDO · Traditional | Instrumentation Laboratory CO | 09/13/1977SE |
| K770831 | Statzyme Uric Acid ReagentCDO · Traditional | Worthington Biochemical Corp. | 07/11/1977SE |
| K770767 | In Vitro Diag. for Uric AcidCDO · Traditional | Smithkline Diagnostics, Inc. | 07/05/1977SE |
| K760989 | Uric Acid Reagent SetCDO · Traditional | Worthington Biochemical Corp. | 12/09/1976SE |