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Enzymatic Method, Creatinine

FDA product code JFY · Class 2 · Clinical Chemistry

93
Registered devices
572
Adverse events
29
Recalls
49
510(k) clearances

Devices with this code

Creatinine Plus — Roche Diagnostics GmbHUrine Reagent Strips — Urit Medical Electronic Co., Ltd.Clinistix Kidney Health Test System — Siemens Healthcare Diagnostics Inc.McKesson — MCKESSON MEDICAL-SURGICAL INC.Dimension Vista® Flex® reagent cartridge ECREA — Siemens Healthcare Diagnostics Inc.Pointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Urine Chemistry Strips — Urit Medical Electronic Co., Ltd.Creatinine LiquiColor® — STANBIO LABORATORY, L.P.Automatic Urine Analyzer — Urit Medical Electronic Co., Ltd.Creatinine plus ver2 — Roche Diagnostics GmbHMultistix® 10 SG Reagent Strips — Siemens Healthcare Diagnostics Inc.ADVIA CHEM Ecre3 — Siemens Healthcare Diagnostics Inc.DrugTect Multi-Drug 14 Drugs Rapid Urine Test Cup — Hangzhou AllTest Biotech Co., Ltd.Urine Reagent Strips — Urit Medical Electronic Co., Ltd.Afinion ACR — Abbott Diagnostics Technologies ASMission U120 Touch Urine Analyzer — Acon Laboratories, Inc.TECO DIAGNOSTICS — TECO DIAGNOSTICSUristix® 4 Reagent Strips — Siemens Healthcare Diagnostics Inc.CARDINAL HEALTH — Cardinal Health 200, LLCAzostix® Reagent Strips — Siemens Healthcare Diagnostics Inc.Multistix® 9 Reagent Strips — Siemens Healthcare Diagnostics Inc.Multistix® 7 Reagent Strips — Siemens Healthcare Diagnostics Inc.Multistix PRO® 10LS Reagent Strips — Siemens Healthcare Diagnostics Inc.

Recent recalls

DateFirmReason
2020-07-13Ortho-Clinical DiagnosticsEtrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
2020-05-04Siemens Healthcare Diagnostics, Inc.The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa
2020-05-04Siemens Healthcare Diagnostics, Inc.The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa
2020-05-04Siemens Healthcare Diagnostics, Inc.The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa
2020-05-04Siemens Healthcare Diagnostics, Inc.The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient sa
2019-12-18Siemens Healthcare Diagnostics, Inc.There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not bee
2019-12-18Siemens Healthcare Diagnostics, Inc.There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not bee
2019-12-18Siemens Healthcare Diagnostics, Inc.There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not bee
2019-12-18Siemens Healthcare Diagnostics, Inc.There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not bee
2019-08-15Beckman Coulter IncIt has been determined that N-acetyl p benzoquinone imine (NAPQI), a metabolite of acetaminophen (paracetamol), may cause negative interference for assays if pr

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.