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Nadh Oxidation/Nad Reduction, Alt/Sgpt

FDA product code CKA · Class 1 · Clinical Chemistry

137
Registered devices
93
Adverse events
18
Recalls
127
510(k) clearances

Devices with this code

CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT ST240 — CAROLINA LIQUID CHEMISTRIES CORPORATIONALANINE AMINOTRANSFERASE (ALT) — RANDOX LABORATORIES LIMITEDPiccolo Liver Panel Plus — ABAXIS, INC.ARCHITECT — ABBOTT IRELANDAlinity — ABBOTT IRELANDALT — RANDOX LABORATORIES LIMITEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.CAROLINA LIQUID CHEMISTRIES CORP.® ALANINE AMINOTRANSFERASE REAGENT KIT BL240 — CAROLINA LIQUID CHEMISTRIES CORPORATIONPiccolo Hepatic Function Panel — ABAXIS, INC.POINTE SCIENTIFIC ALT (SGPT) Liquid — HORIBA INSTRUMENTS INCORPORATEDAlanine Aminotransferase acc. to IFCC II — Roche Diagnostics GmbHAlanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation — Roche Diagnostics GmbHPiccolo General Chemistry 6 — ABAXIS, INC.Piccolo General Chemistry 13 — ABAXIS, INC.BIOBASE — Biobase Biodustry(Shandong)Co., Ltd.Synchron — Beckman Coulter, Inc.ACE — ALFA WASSERMANN, INC.ARCHITECT — ABBOTT LABORATORIESADVIA® Chemistry P5P_c Pyridoxal-5-Phosphate Reagents — Siemens Healthcare Diagnostics Inc.CAROLINA LIQUID CHEMISTRIES CORP.® PHOSPHORUS REAGENT KIT BL218 — CAROLINA LIQUID CHEMISTRIES CORPORATIONALT R2 (w/ssa#) — HORIBA INSTRUMENTS INCORPORATEDBIOBASE — Biobase Biodustry(Shandong)Co., Ltd.POINTE SCIENTIFIC ALT (SGPT) Liquid — HORIBA INSTRUMENTS INCORPORATEDALT (SGPT) LIQUID REAGENT (KINETIC METHOD) — TECO DIAGNOSTICS

Recent recalls

DateFirmReason
2021-06-10Abbott LaboratoriesThere is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for
2021-06-10Abbott LaboratoriesThere is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for
2021-06-10Abbott LaboratoriesThere is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a
2021-06-10Abbott LaboratoriesThere is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for
2017-06-29Siemens Healthcare Diagnostics, Inc.Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine
2017-06-29Siemens Healthcare Diagnostics, Inc.Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine
2017-06-29Siemens Healthcare Diagnostics, Inc.Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine
2016-07-20Sterling Diagnostics, Inc.Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the k
2014-03-05Alfa Wassermann, Inc.Extremely low absorbance readings.
2010-11-19Abaxis, IncorporatedAbaxis has determined that during the manufacture of product lot 0396BC5 may report inaccurate values of Alanine Aminotransferase (ALT) when used in the Piccolo

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