For the quantitative determination of total galactose concentration in dried blo
For the quantitative determination of total galactose concentration in dried blood.Note: Kit contains multiple packages.
NeoBase™ 2 Succinylacetone Assay Solution is intended for in vitro diagnostic us
NeoBase™ 2 Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit and the NeoBase2 Non-derivatized Assay Solutions to extract succinylacetone from blood samples dried on filter paper.
NQL
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
The chemagic 360-D is an automated laboratory instrument used in preanalytical p
The chemagic 360-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.
For the quantitative determination of amino acid, acylcarnitine and free carniti
For the quantitative determination of amino acid, acylcarnitine and free carnitine concentrations in dried blood.
NQL
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
For the quantitative determination of europium (Eu³⁺) in dissociation-enhanced t
For the quantitative determination of europium (Eu³⁺) in dissociation-enhanced time-resolved fluoroimmunoassays.
This reagent package is intended for sample processing in the assay of in vitro
This reagent package is intended for sample processing in the assay of in vitro measurement and evaluation of the concentrations of amino acids, succinylacetone and acylcarnitines in dried blood spot samples (DBS) on filter paper.This reagent package is used together with the NeoBase Non-derivatized MSMS Kit and the NeoBase Succinylacetone Assay Solution.
NQL
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
For the semi-quantitative determination of biotinidase in dried blood. Note: Kit
For the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains multiple packages.
For the semi-quantitative determination of biotinidase in dried blood. Note: Kit
For the semi-quantitative determination of biotinidase in dried blood. Note: Kit contains multiple packages.
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.
JQP
Calculator/Data Processing Module, For Clinical Use
1296-026 DELFIA Platewash is a washer designed for automatic washing of microtit
1296-026 DELFIA Platewash is a washer designed for automatic washing of microtitration strips or plates. It is self-contained, having built-in pumps for vacuum and dispensing and supplied with all the bottles and tubing needed for operation. For use with DELFIA analytes, ready-made programs are accessible.
LXG
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Wallac 1296-071 DBS Puncher is a microprocessor controlled automatic puncher for
Wallac 1296-071 DBS Puncher is a microprocessor controlled automatic puncher for DELFIA® tests performed on filter paper in microplate format. It punches out a disk from a bloodspot on filter paper; this disk then falls into a microtitration well. Punch disk size depends on the punch head installed. Up to 99 disks can be punched into the same well. When the selected number of disks has been punched for a well, the plate is moved to the next position so that the next disk(s) can be punched out. Up to two plates can be loaded to DBS puncher. A microtitration 96-well format plate and Corning Costar deep well tray can be loaded at the same time. Plates consisting of twelve eight-well strips are also supported.
LXG
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Time-resolved fluoroimmunoassay for the quantitative determination of human chor
Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotropin (hCG).
JHJ
Agglutination Method, Human Chorionic Gonadotropin
Time-resolved fluoroimmunoassay for the quantitative determination of human lute
Time-resolved fluoroimmunoassay for the quantitative determination of human luteinizing hormone (hLH).
Time-resolved fluoroimmunoassay for the quantitative determination of human chor
Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotropin (hCG).
JHJ
Agglutination Method, Human Chorionic Gonadotropin
For the quantitative determination of human thyrotropin (thyroid stimulating hor
For the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood.
The NeoBase™ Succinylacetone Assay Solution is intended for in vitro diagnostic
The NeoBase™ Succinylacetone Assay Solution is intended for in vitro diagnostic use with the NeoBase Non-derivatized MSMS Kit and the NeoBase non-derivatized Assay Solutions. The NeoBase™ Succinylacetone Assay Solution is used for the measurement and evaluation of succinylacetone concentration from blood samples dried on filter paper (DBS).
NQL
System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
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.
JQP
Calculator/Data Processing Module, For Clinical Use
Time-resolved fluoroimmunoassay for the quantitative determination of human foll
Time-resolved fluoroimmunoassay for the quantitative determination of human follicle stimulating hormone (hFSH).
The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be
The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be used as an aid in screening with associated AutoDELFIA® reagent kits for neonatal screening and prenatal screening. It is an automatic immunoassay system designed to automatically perform assays using the proven and widely used method of time-resolved fluorometry. It is intended for in vitro quantitative determination of analytes as described by the associated assays. The function, specific disorder, condition or risk factor to be identified, the specimen type, and testing population are based on and described within the intended purpose of the applicable assay. The AutoDELFIA® system is intended to be used by trained laboratory personnel.
The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be
The AutoDELFIA® system (Sample Processor and Plate Processor) is intended to be used as an aid in screening with associated AutoDELFIA® reagent kits for neonatal screening and prenatal screening. It is an automatic immunoassay system designed to automatically perform assays using the proven and widely used method of time-resolved fluorometry. It is intended for in vitro quantitative determination of analytes as described by the associated assays. The function, specific disorder, condition or risk factor to be identified, the specimen type, and testing population are based on and described within the intended purpose of the applicable assay. The AutoDELFIA® system is intended to be used by trained laboratory personnel.
Time-resolved fluoroimmunoassay for the quantitative determination of human chor
Time-resolved fluoroimmunoassay for the quantitative determination of human chorionic gonadotropin (hCG).
JHJ
Agglutination Method, Human Chorionic Gonadotropin
For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration
For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration in dried blood.Note: Kit contains multiple packages.
For the quantitative determination of GALT (galactose-1-phosphate uridyl transfe
For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) activity in dried blood. Note: Kit contains multiple packages.
KQP
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
The GSP® instrument is a fully automated, high throughput batch analyzer for tim
The GSP® instrument is a fully automated, high throughput batch analyzer for time-resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative / qualitative determination of analytes in body fluids. The GSP instrument and GSP chemistries are for professional use only.
Time-resolved fluoroimmunoassay for the quantitative determination of human thyr
Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood.
For the quantitative determination of GALT (galactose-1-phosphate uridyl transfe
For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) in dried blood. Note: Kit contains multiple packages.
KQP
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
For the quantitative determination of GALT (galactose-1-phosphate uridyl transfe
For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) in dried blood. Note: Kit contains multiple packages.
KQP
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
For the quantitative measurement of the activity of certain lysosomal enzymes in
For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots.Note: Kit contains multiple packages.
PQW
Alpha-D-Galactosidase A (Gla) Newborn Screening Test System
Time-resolved fluoroimmunoassay for the quantitative determination of unconjugat
Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).
Time-resolved fluoroimmunoassay for the quantitative determination of unconjugat
Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).
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.
JQP
Calculator/Data Processing Module, For Clinical Use
The device is an automated system, used for extraction and purification of nucle
The device is an automated system, used for extraction and purification of nucleic acid from clinical specimens.
Automated Nucleic Acids Extraction System ANDiS 360
A mains electricity (AC-powered) laboratory instrument intended to be used for t
A mains electricity (AC-powered) laboratory instrument intended to be used for the automated pre-analytical preparation of samples for downstream nucleic acid analysis. The instrument may be used to prepare various sample types through one or more pre-analytical steps which may include cell disruption, lysis, nucleic acid extraction, enzymatic digestion and/or nucleic acid purification. The device operates with minimal technician involvement and complete automation of all procedural steps.
Automated Nucleic Acids Extraction System ANDiS 350
The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic
The ReadiMag Pathogen Nucleic Acid Isolation Kit is a system that uses magnetic beads technology for isolation and purification of Pathogen nucleic acid from biological specimens. The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques.
96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purifica
96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specimens (Nasopharyngeal Swabs, Oropharyngeal Swabs, Saliva and Cervical Swabs) by using automatic magnetic beads technology. The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained.
The 96B Automated Viral RNA Isolation Kit is a system that uses automatic magnet
The 96B Automated Viral RNA Isolation Kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs or saliva). The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques.
32B Automated Viral RNA Isolation Kit is intended for isolation and purification
32B Automated Viral RNA Isolation Kit is intended for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs and saliva ) by using automatic magnetic beads technology, The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained.
96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purifica
96A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specimens by using automatic magnetic beads technology, The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained.
32A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purifica
32A Automated Viral DNA/RNA Isolation Kit is intended for isolation and purification of viral DNA and RNA from biological specimens (nasopharyngeal, oropharyngeal swabs, saliva and cervical swabs) by using automatic magnetic beads technology, The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as laboratory personnel who has been trained.
The ReadiMag FFPE DNA Kit utilizes magnetic beads-based technology for isolation
The ReadiMag FFPE DNA Kit utilizes magnetic beads-based technology for isolation and purification of genomic DNA from formalin-fixed, paraffin-embedded (FFPE) biological specimens.
The ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling kit is a s
The ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens (nasopharyngeal, oropharyngeal swabs or anterior nasal swab). The purified nucleic acids can be directly used for the downstream tests. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques.
ANDiS Viral Nucleic Acid Auto Extraction and Purification Pooling Kit
The 96A Automated Viral RNA Isolation Kit utilizes magnetic beads-based technolo
The 96A Automated Viral RNA Isolation Kit utilizes magnetic beads-based technology for automated isolation and purification of RNA from biological samples. The product is intended to be used by professional users that are trained in molecular biological techniques.
The Viral RNA Auto Extraction & Purification Kit utilize magnetic beads-based te
The Viral RNA Auto Extraction & Purification Kit utilize magnetic beads-based technology for automated isolation and purification of RNA from biological samples.The product is intended to be used by professional users that are trained in molecular biological techniques.
The ANDiS Viral RNA Auto Exttaction & Purification Kit is a system that uses au
The ANDiS Viral RNA Auto Exttaction & Purification Kit is a system that uses automatic magnetic beads technology for isolation and purification of viral RNA from biological specimens. The product is intended to be used by professional users, such as technicians and physicians who are trained in molecular biological techniques. The ANDiS Viral RNA Auto Extraction & Purification Kit is intennded for in vitro diagnostic use.
ANDiS Viral RNA Auto Extraction & Purification Kit
The chemagic 360-D is an automated laboratory instrument used in preanalytical p
The chemagic 360-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.
The chemagic Prepito-D is an automated laboratory instrument used in preanalytic
The chemagic Prepito-D is an automated laboratory instrument used in preanalytical preparation of samples through magnetic particle separation technology for use with in vitro diagnostic clinical sample concentrating kits. The instrument is intended for use by healthcare professionals such as laboratory personnel or physicians who are trained in molecular biology techniques.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It
The Vivapore device is a single-use concentrator for in-vitro diagnostic use. It is particularly effective for the concentration of urine for the detection of Bence Jones proteinuria found in patients with myelomatosis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
This single-use device can be used for In Vitro Diagnostic applications, it is s
This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.
MagXtract 3200 Automated Nucleic Acid Extraction SystemThe MagXtract 3200 system
MagXtract 3200 Automated Nucleic Acid Extraction SystemThe MagXtract 3200 system is an automated nucleic acid purification and PCR reaction preparation system consisting of MagXtract 3200 instrument, software and consumables. It must be used in combination with the authorized extraction kits which have been validated according to the IVD or other relevant regulations to perform the nucleic acid purifications. The MagXtract 3200 System is intended for use by professional users for the purification of nucleic acids and PCR sample prep from human samples for in vitro diagnostic purposes.Product Use Limitations:The MagXtract 3200 instrument is intended for indoor use only. The user is responsible for establishing performance characteristics necessary for downstream diagnostic applications. Appropriate controls must be included in any downstream diagnostic applications using nucleic acids, purified by the instruments.