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Sources: EU EUDAMED, US FDA
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Pentra C400 (version 1.1.2 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Enforcement
Class II
·Terminated·Horiba Instruments Inc·May 4, 2016
ABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Enforcement
Class II
·Terminated·Horiba Instruments Inc·May 4, 2016
Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product Model #: D00A00224D The Lite DM (Lite Data Manager) is a software application developed by HORIBA Medical intended to receive, store, and manage Startup, Patient, and Quality Control (QC) results from an ABX Micros 60 Hematology Analyzer or ABX Micros CRP 200 Hematology Analyzer. Only one instrument connection is allowed per each Lite DM workstation. The Lite DM application runs on a PC within a Windows Operating System platform. Data transmitted from the instrument to the Lite DM workstation is a Serial RS-232 unidirectional ABX Format communication. The Lite DM can act as a standalone data manager for data received from the instrument, or allow transmission of this data to a Host (LIS Laboratory Information System or EMR Electronic Medical Record system). Following the completion of each blood sample analysis performed on the connected HORIBA Medical hematology analyzer, results are then communicated (uni-directional) to the Lite DM workstation. Results received will display to the user in a specific color coding format indicating any normal or panic reference range violations. Results are then rejected or accepted by the user for final reporting - formatted to guidelines stipulated by CLIA. At no time are any results interpreted; only reported for review and appropriate action.
FDA Enforcement
Class II
·Terminated·Horiba Instruments Inc·December 31, 2014
ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
FDA Enforcement
Class II
·Terminated·Horiba Instruments Inc·February 10, 2016
ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction.
FDA Enforcement
Class II
·Terminated·Horiba Instruments Inc·February 10, 2016
ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.
FDA Enforcement
Class II
·Terminated·Horiba Instruments Inc·February 10, 2016
ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
FDA Enforcement
Class II
·Terminated·Horiba Instruments Inc·February 10, 2016
ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase (Trinder method).
FDA Enforcement
Class II
·Terminated·Horiba Instruments Inc·February 10, 2016
The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with additives.
FDA Enforcement
Class II
·Terminated·Horiba Instruments Inc·February 10, 2016
10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400
FDA Enforcement
Class II
·Terminated·Horiba Instruments, Inc dba Horiba Medical·February 7, 2018
15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400
FDA Enforcement
Class II
·Terminated·Horiba Instruments, Inc dba Horiba Medical·February 7, 2018
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
FDA Enforcement
Class II
·Terminated·Horiba Instruments, Inc dba Horiba Medical·July 4, 2018
ABX PENTRA ML, Software Versions: V8.0.x and Below; V.9.0.1 and V9.0.2
FDA Enforcement
Class II
·Terminated·Horiba Instruments, Inc dba Horiba Medical·January 16, 2013
ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-level (Low and High) quality control consisting of liquid solutions prepared from human urine with chemical additives and materials of biological origin added as required to obtain given component levels. The assigned values of the control components are given in the labeling, ensuring control of the appropriate HORIBA ABX SAS methods on the ABX PENTRA chemistry analyzers. Each control level is provided in one vial of 10 ml. The ABX PENTRA Urine Control L/H is for use in quality control by monitoring accuracy and precision.
FDA Enforcement
Class III
·Terminated·Horiba Instruments, Inc dba Horiba Medical·February 12, 2014
ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed annex.
FDA Enforcement
Class II
·Terminated·Horiba Instruments, Inc dba Horiba Medical·February 12, 2014
ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.
FDA Enforcement
Class III
·Terminated·Horiba Instruments, Inc dba Horiba Medical·November 21, 2012
ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Control. The ABX PENTRA 400 and PC200 are benchtop clinical chemistry analyzers using two measuring principals: absorbance and ion selective electrodes. The ABX PENTRA Multical is a lyophilized human serum calibrator with chemical additives and materials of biological origin. The assigned values of the calibrator components are given in the enclosed annex, ensuring optimal calibration of the appropriate HORIBA ABX SAS methods on the ABX PENTRA Clinical Chemistry Analyzer. This calibrator is provided in ten vials of 3 ml.
FDA Enforcement
Class II
·Terminated·Horiba Instruments, Inc dba Horiba Medical·March 12, 2014
Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers.
FDA Enforcement
Class II
·Terminated·Horiba Instruments, Inc dba Horiba Medical·March 19, 2014
ABX PENTRA AST CP, Part Number: A11A01629. The ABX Pentra AST CP reagent is a diagnostic reagent for quantitative in vitro determination of Aspartate Amino Transferase (AST) in serum or plasma by colorimetry.
FDA Enforcement
Class II
·Terminated·Horiba Instruments, Inc dba Horiba Medical·January 9, 2013
ABX PENTRA Calcium CP Reagent, Model # A11A01633 Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.
FDA Enforcement
Class III
·Terminated·Horiba Instruments, Inc dba Horiba Medical·October 2, 2013