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510(k) Data Aggregation
K Number
DEN240035Device Name
ConcizuTrace ELISA
Manufacturer
Randox Laboratories Ltd
Date Cleared
2025-05-22
(325 days)
Product Code
SES
Regulation Number
864.7298Why did this record match?
Applicant Name (Manufacturer) :
Randox Laboratories Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K230890Device Name
ISE Electrodes
Manufacturer
Randox Laboratories Ltd.
Date Cleared
2023-09-08
(161 days)
Product Code
CEM, CGZ, JGS
Regulation Number
862.1600Why did this record match?
Applicant Name (Manufacturer) :
Randox Laboratories Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ISE Electrodes on the RX Imola can be used for measurement of the electrolytes sodium, potassium and chloride in serum and urine and for use in diagnosis and treatment of electrolyte imbalance. For in vitro diagnostic use only.
Device Description
RX imola is an automated clinical chemistry analyzer complete with dedicated analyzer software. Software functions of the analyzer include the facility to interact with a host computer for direct download of test method selection details for individual samples. A barcode system is used for the rapid identification of patient samples, reagents and QC samples, In addition, the RX imola is fitted with an Ion Selective Electrode (ISE) module that operates in conjunction with specific electrodes for the quantitative in vitro diagnostic determination of Sodium, Potassium and Chloride in serum and urine.
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K Number
K182042Device Name
Randox Calcium (Ca)
Manufacturer
Randox Laboratories Ltd.
Date Cleared
2018-10-23
(85 days)
Product Code
CJY
Regulation Number
862.1145Why did this record match?
Applicant Name (Manufacturer) :
Randox Laboratories Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.
Device Description
The Randox Calcium (Ca) kit consists of a ready to use reagent solution.
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K Number
K162200Device Name
Randox RX Daytona Plus Magnesium (MG)
Manufacturer
RANDOX LABORATORIES LTD
Date Cleared
2017-04-28
(266 days)
Product Code
JGJ
Regulation Number
862.1495Why did this record match?
Applicant Name (Manufacturer) :
RANDOX LABORATORIES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Randox RX daytona plus magnesium (Mg) test system is intended for the quantitative in vitro determination of magnesium concentration in serum, urine and lithium heparinized plasma. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium).
Device Description
The Magnesium kit assay consists of a ready to use reagent solution.
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K Number
K152085Device Name
Liquid CO2-2 (LCO2-2)
Manufacturer
RANDOX LABORATORIES LTD
Date Cleared
2016-02-24
(212 days)
Product Code
KHS
Regulation Number
862.1160Why did this record match?
Applicant Name (Manufacturer) :
RANDOX LABORATORIES LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the quantitative in vitro determination of Carbon Dioxide in serum and plasma. Carbon Dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance.
This in vitro diagnostic device is intended for Rx Only.
Device Description
The Liquid CO2-2 (LCO2-2) kit assay consists of ready to use reagent solutions.
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K Number
K153435Device Name
Direct HDL Cholesterol (HDL)
Manufacturer
Randox Laboratories Ltd
Date Cleared
2016-01-08
(42 days)
Product Code
LBS
Regulation Number
862.1475Why did this record match?
Applicant Name (Manufacturer) :
Randox Laboratories Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the quantitative in vitro determination of HDL Cholesterol in serum and plasma. Such measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and renal diseases and for the assessment for the risk of developing cardiovascular disease.
This in vitro diagnostic device is intended for Rx Only.
Device Description
The Direct HDL Cholesterol (HDL) kit assay consists of ready to use reagent solutions.
CATALOGUE NUMBER: CH8311
R1. Enzyme Reagent 1 4 x 20 ml
R2. Enzyme Reagent 2 4 x 9 ml
REAGENT COMPOSITION
R1. Enzyme Reagent 1 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid N-(2-hydroxy-3-Sulfopropyl)- 3,5-dimethoxyaniline, sodium salt (HDAOS) Cholesterol Esterase [E.C.3.1.1.13. Microorganism] Cholesterol Oxidase [E.C.1.1.3.6. Streptomyces sp] Catalase [E.C.1.11.1.6. Microbial] Ascorbate oxidase [EC.1.10.3.3. Acremonium sp.] Initial Concentration of Solution 100 mM, pH 6.6 (+25 °C) 0.7 mM ≥800 U/L ≥500 U/L ≥300 KU/L ≥3000 U/L
R2. Enzyme Reagent 2 N,N-Bis(2-hydroxyethyl)- 2-aminoethanesulfonic acid 4-Aminoantipyrine Peroxidase [E.C.1.11.1.7, Horse Radish, +25°C] Sodium Azide Surfactants Initial Concentration of Solution 100 mM, pH 7.0 (+25 °C) 4.0 mM ≥3500 U/L 0.05 w/v % 1.4 % w/v %
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