Home › Device types › KNK
Acid, Uric, Uricase (Colorimetric)
FDA product code KNK · Class 1 · Clinical Chemistry
109
Registered devices
24
Adverse events
15
Recalls
118
510(k) clearances
Devices with this code
Synermed® — INFRARED LABORATORY SYSTEMS LLCUric Acid ver.2 — Roche Diagnostics GmbHACE — ALFA WASSERMANN, INC.ADVIA® Chemistry UA Uric Acid Reagents — Siemens Healthcare Diagnostics Inc.ACE — ALFA WASSERMANN, INC.Teco Diagnostics Uric Acid Reagent Set — TECO DIAGNOSTICSCAROLINA LIQUID CHEMISTRIES CORP.® URIC ACID REAGENT KIT AU-212 — CAROLINA LIQUID CHEMISTRIES CORPORATIONJAS Diagnostics — DREW SCIENTIFIC, INC.JAS Diagnostics — DREW SCIENTIFIC, INC.Uric Acid ver.2 — Roche Diagnostics GmbHAlinity — Abbott GmbHTeco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-480 — TECO DIAGNOSTICSUric Acid Reagent — CLINICAL DIAGNOSTIC SOLUTIONS, INC.AU — Beckman Coulter, Inc.Pointe Scientific, Inc. Uric Acid — HORIBA INSTRUMENTS INCORPORATEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.ADVIA® Chemistry UA_c Uric Acid Reagents, Concentrated — Siemens Healthcare Diagnostics Inc.MedTest DX Uric Acid for the BS480 — Medtest Dx, Inc.Uric Acid LiquiColor® — STANBIO LABORATORY, L.P.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Pointe Uric Acid Reagent — HORIBA INSTRUMENTS INCORPORATEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Uric Acid — HORIBA INSTRUMENTS INCORPORATED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-02 | DFI Co., Ltd. | The devices were distributed without required FDA premarket clearance or approval. |
| 2019-08-15 | Beckman Coulter Inc | It has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if pr |
| 2018-08-24 | Beckman Coulter Inc. | NAPQI, a metabolite of Acetominophen, causes negative interference with the recalled product assays at levels present in the serum/plasma of overdose patients. |
| 2017-04-03 | Beckman Coulter Inc. | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result |
| 2016-08-11 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplemen |
| 2016-04-13 | Beckman Coulter Inc. | Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6 |
| 2016-03-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. |
| 2016-03-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. |
| 2016-03-17 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. |
| 2016-01-11 | Horiba Instruments Inc | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide cat |
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