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Enzymatic Method, Creatinine

FDA product code JFY · Class 2 · Clinical Chemistry

91
Registered devices
563
Adverse events
29
Recalls
49
510(k) clearances

Devices with this code

Multistix® 8 SG Reagent Strips — Siemens Healthcare Diagnostics Inc.ADVIA® Chemistry ECRE_2 Creatinine_2 Reagents (Enzymatic) — Siemens Healthcare Diagnostics Inc.Afinion HbA1c — Abbott Diagnostics Technologies ASURiSCAN 2 ACR strip — YD Diagnostics CORP.CLINITEK Status® Connector — Siemens Healthcare Diagnostics Inc.Creatine Kinase — Roche Diagnostics GmbHPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDPointe Creatinine Enzymatic on BS480 — HORIBA INSTRUMENTS INCORPORATEDCARDINAL HEALTH — Cardinal Health 200, LLCMultistix PRO® 10LS Reagent Strips — Siemens Healthcare Diagnostics Inc.Azostix® Reagent Strips — Siemens Healthcare Diagnostics Inc.Automatic Urine Analyzer — Urit Medical Electronic Co., Ltd.TECO DIAGNOSTICS — TECO DIAGNOSTICSMission Urinalysis Reagent Strips — Acon Laboratories, Inc.Clinitek AtlasPRO® 12 Reagent PAK for Urine Chemistry — Siemens Healthcare Diagnostics Inc.CR Cartridge — LifehealthPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDSynchron — Beckman Coulter, Inc.ABX PENTRA ENZYMATIC CREATININE CP — HORIBA ABX SASAutomatic Urine Analyzer — Urit Medical Electronic Co., Ltd.ARCHITECT — ABBOTT LABORATORIESCreatinine plus ver2 — Roche Diagnostics GmbHCreatinine plus ver2 — Roche Diagnostics GmbHPointe Scientific, Inc. Creatinine Enzymatic — HORIBA INSTRUMENTS INCORPORATED

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.