Strip Description: For the in vitro quantitative determination of magnesium con
Strip Description: For the in vitro quantitative determination of magnesium concentration in human plasma from whole blood samples.
Strip Description: For the in vitro quantitative determination of total protein
Strip Description: For the in vitro quantitative determination of total protein in human plasma from whole blood samples.
Strip Description: For the in vitro quantitative determination of total bilirub
Strip Description: For the in vitro quantitative determination of total bilirubin concentration in human plasma from whole blood samples.
Strip Description: For the in vitro quantitative determination of total cholest
Strip Description: For the in vitro quantitative determination of total cholesterol in human plasma from whole blood samples.
GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose t
GLUCOCARD Shine Level 1 Control Solution contains a specific amount of glucose that is used to check the performance of the meter and test strips. The test results you obtain should fall within the control solution range printed on the vial of test strips. (Primary UPC# 015482540050 is used as the assigned UDI for the Class I device.)
JJX
Single (Specified) Analyte Controls (Assayed And Unassayed)
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle
Sterile Safety Syringe, Antistick. Retractable Safety Syringe with fixed needle is a sterile, single use, safety syringe that is used to inject fluids into, or withdraw fluids from the body. Designed to aid in prevention of needle stick injuries.
Insulin Safety Pen Needle. Intended to be used with a pen injector device for t
Insulin Safety Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Urine Analyzer utilize reflectance technology with with AUTION Strips reagent t
Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity.
JMT,JIN,JRE,JIR,JJB,JIO,KQO,CEN,CDM,JIL,LJX
DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT),NITROPRUSSIDE, KETONES (URINA
DIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT),NITROPRUSSIDE, KETONES (URINARY, NON-QUANT.),REFRACTOMETER FOR CLINICAL USE,INDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.),AZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.),BLOOD, OCCULT, COLORIMETRIC, IN URINE,AUTOMATED URINALYSIS SYSTEM,DYE-INDICATOR, PH (URINARY, NON-QUANT.),DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.),METHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE),TEST, URINE LEUKOCYTE
Aution AU Control Solution is supplied in 2 different levels (High and Low) and
Aution AU Control Solution is supplied in 2 different levels (High and Low) and is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION HYBRID AU-4050 flow cytometry model. (Primary UPC/EAN-13# 4987486738060 is used as the assigned UDI for the Class I device.)
The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used fo
The Calibrator 80 is for the calibration of the ADAMS A1c HA-8180 system used for the quantitative determination of Hemoglobin A1c (HbA1c) in human whole blood and hemolysate samples. Bi-level calibrators (low and high) lyophilized calibrator from human-sourced hemoglobin.
The ADAMS A1c HA-8180V system is intended for the quantitative determination of
The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC).
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Strip Description: For the in vitro quantitative determination of HDL-Cholester
Strip Description: For the in vitro quantitative determination of HDL-Cholesterol in human plasma from whole blood samples.
Strip Description: For the in vitro quantitative determination of lactate dehyd
Strip Description: For the in vitro quantitative determination of lactate dehydrogenase (LDH) activity in human plasma from whole blood samples.
CFH
TETRAZOLIUM INT DYE-DIAPHORASE, LACTATE DEHYDROGENASE
Strip Description: For the in vitro quantitative determination of ALT (alanine
Strip Description: For the in vitro quantitative determination of ALT (alanine aminotransferease or glutamic pyruvic transaminase) activity in human plasma from whole blood samples.
The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the
The GLUCOCARD Shine Express Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.
NBW
System, Test, Blood Glucose, Over The Counter
2
GLUCOCARD® Shine Express Blood Glucose Monitoring System
The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quant
The GLUCOCARD Shine XL Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in freshcapillary whole blood samples drawn from the fingertips and alternative sites such as the forearm, palm, thigh and calf.
NBW
System, Test, Blood Glucose, Over The Counter
2
GLUCOCARD® Shine XL Blood Glucose Monitoring System
The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantita
The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes.
The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantita
The GLUCOCARD Shine Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and alternative sites such as forearm, palm, thigh, and calf. Alternative site testing should be used only during steady-state blood glucose conditions. The GLUCOCARD Shine Blood Glucose Monitoring System is intended for self testing outside the body (in vitro) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The system is intended to be used by a single person and should not be shared. It is not intended for use on neo nates and is not for the diagnosis or screening of diabetes.
Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the qua
Blood Glucose Test Strips. Assure Platinum Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (in vitro diognostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as a aid to monitor the effectiveness of diabetes control.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of drugs.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Insulin Pen Needle. Intended to be used with a pen injector device for the subc
Insulin Pen Needle. Intended to be used with a pen injector device for the subcutaneous injection of insulin.
Urine Analyzer utilize reflectance technology with with AUTION Strips reagent t
Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity.
Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial
Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment.
Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL o
Aution Check Plus Controls is supplied in 2 different levels (2 bottles x 25mL of each level per box). They are supplied in liquid form, requiring no pretreatment or dilution. They are prepared by adding various compounds to human urine so that the desired reaction occurs during quality control. Preservatives have been added to prevent bacteria growth. (Primary UPC/EAN-13# 4987486009801 is used as the assigned UDI for the Class I device.)
Strip Description: For the in vitro quantitative determination of fructosamine
Strip Description: For the in vitro quantitative determination of fructosamine in human plasma from whole blood samples.
Strip Description: For the in vitro quantitative determination of GGT (y-glutam
Strip Description: For the in vitro quantitative determination of GGT (y-glutamyltransferase or y-glutamyl tanspeptidase, Y-GPT) activity in human plasma from whole blood samples.
This media contains V 7.4 of the following registered Medical Devices:(DI)091200
This media contains V 7.4 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
This media contains V 7.3 of the following registered Medical Devices:(DI)091200
This media contains V 7.3 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
This media contains V 7.4 of the following registered Medical Devices:(DI)091200
This media contains V 7.4 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
This media contains the following registered Medical Devices:(DI) 09120052070996
This media contains the following registered Medical Devices:(DI) 09120052070996 MAGELLAN V7.X(DI) 09120052071009 MAGELLAN TRACKER V7.X
This media contains V 7.3 of the following registered Medical Devices:(DI)091200
This media contains V 7.3 of the following registered Medical Devices:(DI)09120052070880 (SOFTWARE MAGELLAN PRO V 7.X),(DI)09120052070910 (SOFTWARE MAGELLAN PRO TRACKER V 7.X)
ProTube is designed to automate biological sample collection process. ProTube en
ProTube is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. ProTube is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers, sample check-out and monitoring of transport parameters.
The ProTube System is designed to automate biological sample collection process.
The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out.
The MSMS Workstation is intended for use as a calculator/data processing softwar
The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data.
Specimen Gate® Screening Center™ is intended to be used for data management of n
Specimen Gate® Screening Center™ is intended to be used for data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
Specimen Gate® Laboratory is a modular laboratory information management system
Specimen Gate® Laboratory is a modular laboratory information management system intended for use as a calculator/data processing software for the storage, retrieval, and processing of laboratory data in newborn screening laboratories.
Specimen Gate® PatientCare™ is intended for management of the follow-up workflow
Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening system.
EKF Link is a data and device management system that enables healthcare professi
EKF Link is a data and device management system that enables healthcare professionals to transfer, manage, store and display measurement results from point -of-care diagnostic testing analyzers. EKF Link enables the allocation of additional information to measurement results and facilitates the export or transfer of data for documentation purposes.EKF Link is intended to be used as an optional software application with EKF point -of-care analyzers and open to be interfaced to other vendor’s point-of-care testing analyzers verified for connection with EKF Link.EKF Link facilitates the setting of configurable options of connected analyzers.
TD-Web is a web solution to easily manage orders creation, optimize collection
TD-Web is a web solution to easily manage orders creation, optimize collection management and provide real-time results access at the patient’s bedside.
TDWorkstation is a powerful software designed to interface instruments with any
TDWorkstation is a powerful software designed to interface instruments with any Laboratory Information System (LIS) and manage results with efficiency and flexibility.
TDHisto/Cyto is a software used for managing medical information in the field
TDHisto/Cyto is a software used for managing medical information in the field of laboratories performing histology, non-gynecological and gynecological cytology and autopsy activities..
TDNexLabs is a Laboratory Information System (LIS) (software product) intended t
TDNexLabs is a Laboratory Information System (LIS) (software product) intended to be used for the management of clinical information.TDNexLabs is intended to be used only by health professionals.
a calculator/data processing module for clinical use described as electronic dev
a calculator/data processing module for clinical use described as electronic device intended to store, retrieve, and process laboratory data.
The Telserve® Data Management System is an accessory to blood glucose monitoring
The Telserve® Data Management System is an accessory to blood glucose monitoring systems for the review and evaluation of blood glucose test results to aid in diabetes management.