RANDOX LABORATORIES-US, LTD

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• randox.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• Evidence MultiSTAT DOA Urine MultiPlex

  2023-10-05

  Randox Laboratories Limited

• Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT

  2023-10-05

  Randox Laboratories Limited

• ISE Electrodes

  2023-09-08

  Randox Laboratories, Ltd.

• Randox Calcium (Ca)

  2018-10-23

  Randox Laboratories Ltd.

• Randox RX Daytona Plus Magnesium (MG)

  2017-04-28

  RANDOX LABORATORIES LTD

• Randox RX Daytona Plus Alkaline Phosphatase (ALP)

  2017-04-21

  RANDOX LABORATORIES LIMITED

• Direct LDL Cholesterol (LDL)

  2017-03-20

  RANDOX LABORATORIES LIMITED

• Liquid CO2-2 (LCO2-2)

  2016-02-24

  RANDOX LABORATORIES LTD

• Direct Bilirubin

  2016-02-16

  RANDOX LABORATORIES LIMITED

• Total Bilirubin

  2016-01-28

  RANDOX LABORATORIES LIMITED

• Direct HDL Cholesterol (HDL)

  2016-01-08

  Randox Laboratories Ltd

• Cholesterol

  2015-09-29

  RANDOX LABORATORIES, LTD.

• Triglycerides

  2015-08-06

  Randox Laboratories Limited

• LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.

  2014-12-08

  RANDOX LABORATORIES LIMITED

• RANDOX ALDOLASE CALIBRATION SERUM

  2014-09-18

  RANDOX LABORATORIES LIMITED

• RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL

  2014-05-22

  RANDOX LABORATORIES LIMITED

• RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3

  2014-03-25

  RANDOX LABORATORIES LIMITED

• RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT

  2014-01-09

  RANDOX LABORATORIES, LTD.

• RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

  2013-11-21

  RANDOX LABORATORIES, LTD.

• RANDOX CSF CONTROLS LEVELS 2 AND 3

  2013-10-23

  RANDOX LABORATORIES, LTD.

• BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2

  2013-08-08

  RANDOX LABORATORIES, LTD.

• HBA1C CONTROL, LEVEL 1 AND LEVEL 2

  2013-07-26

  RANDOX LABORATORIES, LTD.

• ALDOLASE CONTROLS LEVEL 2, AND ALDOLASE CONTROL LEVEL 3

  2013-07-18

  RANDOX LABORATORIES, LTD.

• RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3

  2013-06-19

  RANDOX LABORATORIES LIMITED

• RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3

  2012-11-20

  RANDOX LABORATORIES, LTD.

• RANDOX MATERNAL CONTROL, LEVELS 1, 2 AND 3

  2012-09-20

  RANDOX LABORATORIES, LTD.

• RANDOX OPIATES ASSAY

  2012-08-24

  RANDOX LABORATORIES LIMITED

• DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

  2012-08-14

  RANDOX LABORATORIES LIMITED

• RANDOX MICROALBUMIN CONTROL LEVEL 1 AND CONTROL LEVEL 2 (LIQUID)

  2012-07-11

  RANDOX LABORATORIES, LTD.

• RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3

  2012-06-20

  RANDOX LABORATORIES, LTD.

• RANDOX COCAINE METABOLITE

  2012-05-08

  RANDOX LABORATORIES, LTD.

• RANDOX LIQUID CARDIAC CONTROL LEVELS 1, 2 AND 3

  2012-01-23

  RANDOX LABORATORIES LIMITED

• RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVEL

  2011-12-01

  RANDOX LABORATORIES, LTD.

• RANDOX DIGOXIN ASSAY

  2011-10-14

  RANDOX LABORATORIES, LTD.

• RANDOX LIQUID URINE CONTROL LEVELS 2 AND 3

  2011-09-30

  RANDOX LABORATORIES, LTD.

• RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2

  2011-09-30

  RANDOX LABORATORIES LIMITED

• RANDOX BARITURATES ASSAY

  2011-05-25

  RANDOX LABORATORIES, LTD.

• RANDOX METHAMPHETAMINE ASSAY

  2011-05-09

  RANDOX LABORATORIES, LTD.

• CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET

  2011-04-08

  RANDOX LABORATORIES, LTD.

• RANDOX ECSTASY (MDMA) ASSAY

  2011-03-01

  RANDOX LABORATORIES, LTD.

131 records. Showing 1-40. Next

GUDID#

• AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-09

• P AMY - The device is intended for the quantitative in vitro determination of pancreatic α amylase in serum, plasma and urine.

  RANDOX LABORATORIES LIMITED

  2016-09-09

• AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-09

• AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-09

• P AMY - A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-09

• AMY - An α-amylase test system is a device intended for the quantitative in vitro determination of α-amylase activity in serum, plasma or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-09

• P AMY - A Pancreatic α‑Amylase test system is a device intended for the quantitative in vitro determination of Pancreatic α‑Amylase activity in serum, plasma or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-09

• AMY - The AMY method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of amylase activity in serum, plasma and urine.

  RANDOX LABORATORIES LIMITED

  2016-09-09

• AMY - The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-09

• AMY - The amylase test system is intended for the quantitative in vitro determination of Amylase in serum, plasma or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-09

• BASELINE SELF-DRAW Premium Home Blood Sampling Collection Kit - The Baseline Self-Draw (Premium Home Blood Sampling Collection Kit) is intended for use in the collection and transport of a capillary blood samples for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. Samples may be collected at home through adherence to the Instructions for Use (IFU) or may be collected under the guidance of a medical professional.

  RANDOX LABORATORIES LIMITED

  2026-05-22

• FEMALE HORMONE Premium Home Blood Sampling Collection Kit - The Female Hormone (Premium Home Blood Sampling Collection Kit) is intended for use in the collection and transport of a capillary blood samples for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. Samples may be collected at home through adherence to the Instructions for Use (IFU) or may be collected under the guidance of a medical professional.

  RANDOX LABORATORIES LIMITED

  2026-05-22

• BASELINE Venous Sample Collection kit - The Baseline (Venous Sample Collection Kit) is intended for use in the collection and transportation of a blood sample taken by trained phlebotomist for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. The sample will be collected in a home and/or clinical environment and transported to a professional laboratory for analysis.

  RANDOX LABORATORIES LIMITED

  2026-05-22

• MALE HORMONE Premium Home Blood Sampling Collection Kit - The Male Hormone (Premium Home Blood Sampling Collection Kit) is intended for use in the collection and transport of a capillary blood samples for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. Samples may be collected at home through adherence to the Instructions for Use (IFU) or may be collected under the guidance of a medical professional.

  RANDOX LABORATORIES LIMITED

  2026-05-22

• BIOHACKER Premium Home Blood Sampling Collection Kit - The Biohacker (Premium Home Blood Sampling Collection Kit) is intended for use in the collection and transport of a capillary blood samples for use in biochemical laboratory analysis. This device is intended for sample collection purposes only. Samples may be collected at home through adherence to the Instructions for Use (IFU) or may be collected under the guidance of a medical professional.

  RANDOX LABORATORIES LIMITED

  2026-05-22

• COAGULATION CALIBRATOR (COAG CAL) - CG5037

  RANDOX LABORATORIES LIMITED

  2019-06-03

• COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3) - CG5023

  RANDOX LABORATORIES LIMITED

  2019-06-03

• COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2) - CG5022

  RANDOX LABORATORIES LIMITED

  2019-06-03

• COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) - CG5021

  RANDOX LABORATORIES LIMITED

  2019-06-03

• APOLIPOPROTEIN E (APO E) - LP3864

  RANDOX LABORATORIES LIMITED

  2019-06-03

• ALB - An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum.

  RANDOX LABORATORIES LIMITED

  2016-09-16

• ALB - An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.

  RANDOX LABORATORIES LIMITED

  2016-09-16

• ALB - An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.

  RANDOX LABORATORIES LIMITED

  2016-09-16

• ALB - An Albumin test system is a device intended for the quantitative in vitro determination of Albumin concentration in serum and plasma.

  RANDOX LABORATORIES LIMITED

  2016-09-16

• GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL) - GR2609

  RANDOX LABORATORIES LIMITED

  2019-06-03

• GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL) - GR2608

  RANDOX LABORATORIES LIMITED

  2019-06-03

• GLUTATHIONE REDUCTASE (GLUT RED) - GR2368

  RANDOX LABORATORIES LIMITED

  2019-06-03

• ConcizuTrace™ ELISA - The ConcizuTrace™ ELISA device is for use in determining the concentration of the drug, concizumab, in 3.2% citrated plasma from patients with Haemophilia A & B, with and without inhibitors, who are undergoing treatment with concizumab for routine prophylaxis of bleeding episodes. The device is a sandwich ELISA. The intended users are trained laboratory professionals.

  RANDOX LABORATORIES LIMITED

  2025-05-30

• I.S.E. REF - Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-26

• L SOLN - Used as a Calibrator in a two-point calibration. L Solution is pumped into the sample port by the L Solution pump and then positioned in front of the sensor.

  RANDOX LABORATORIES LIMITED

  2016-09-26

• I.S.E. CL - Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-26

• I.S.E. K - Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-26

• I.S.E. NA - Intended for use with the Ion Selective Electrode unit for measuring concentration of electrolytes in the blood serum, plasma or urine.

  RANDOX LABORATORIES LIMITED

  2016-09-26

• AWS - This product should be used in conjunction with RX daytona plus reagents to clean probes and cuvettes.

  RANDOX LABORATORIES LIMITED

  2016-09-26

• SABS - This product is used for checking proper functioning of the sample fluid metering system as well as the photometric measuring system.

  RANDOX LABORATORIES LIMITED

  2016-09-26

• ISE DIL - The product is intended for use in the measurement of urine samples.

  RANDOX LABORATORIES LIMITED

  2016-09-26

• ETCH - This should be run on a weekly basis to prevent protein build up.

  RANDOX LABORATORIES LIMITED

  2016-09-26

• I.S.E. CLN - The product should be run on a weekly basis to prevent protein build up.

  RANDOX LABORATORIES LIMITED

  2016-09-26

• H SOLN - Used as a Calibrator in a two-point calibration. H Solution is aspirated from a sample cup located in a pre-registered position on the sample carousel.

  RANDOX LABORATORIES LIMITED

  2016-09-26

• REF SOLN - This is required for measuring reference electrode potential of an ion selective electrode module.

  RANDOX LABORATORIES LIMITED

  2016-09-26

80 records. Showing 1-40. Next