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.

Used with 1235-5110 AutoDELFIA® Plate Processor System or 1235-5220 AutoDELFIA® System (SP and PP).

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.

Used with 1235-5220 AutoDELFIA® System (SP and PP).

The VICTOR EnLite instrument is intended for the quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on a filter paper as an aid in screening newborns for severe combined immunodeficiency (SCID) using the polymerase chain reaction (PCR) based EnLite Neonatal TREC kit.

The VICTOR EnLite instrument is intended for the quantitative determination of TREC (T-cell receptor excision circle) DNA in blood specimens dried on a filter paper as an aid in screening newborns for severe combined immunodeficiency (SCID) using the polymerase chain reaction (PCR) based EnLite Neonatal TREC kit.

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.

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.

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.

Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS. Panthera-Puncher 9 is cabable of handling up to 9 pcs of 96-well microtiter plates simultaneously. Panthera-Puncher contains a camera for imaging of the sample card and for blood detection.

Migele™ Gel Electrophoresis Unit (GEU) is intended for professional use together with power supply, water bath and isoelectric focusing (IEF) gels. GEU is used for the isoelectric point-based separation of sample compounds, e.g. hemoglobin variants found in blood samples, by applying a given amount of electrical current to the immobilized pH-gradient containing agarose.

For the quantitative determination of amino acid, acylcarnitine and free carnitine concentrations in dried blood.

NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations from newborn heel prick blood samples dried on filter paper.

NeoBase™ 2 Non-derivatized Assay Solutions are intended for in vitro diagnostic use with the NeoBase 2 Non-derivatized MSMS kit to extract target analytes from blood samples dried on filter paper and to carry target analytes to the MSMS system.

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.

For the quantitative measurement of the activity of certain lysosomal enzymes in dried blood spots.Note: Kit contains multiple packages.

For DNA extraction from human plasma or blood.

The Eonis DNA Extraction kit is a device intended for isolation and purification of DNA in newborn blood specimens dried on filter paper.

The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP30 DNAs.

The Eonis SCID-SMA kit is a device intended for PCR amplification of sjTREC, KREC, SMN1 and RPP30 DNAs.

The DBS Controls M2 is intended for use as an external control material to evaluate the performance of lysosomal enzyme activity.This product has no qualitative or quantitative assigned value. This control is not intended for any specific patient population or specimen.

For the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood.

For the quantitative determination of thyroxine (T4) in dried blood.

For the quantitative determination of GALT (galactose-1-phosphate uridyl transferase) activity in dried blood. Note: Kit contains multiple packages.

For the quantitative determination of europium (Eu³⁺) in dissociation-enhanced time-resolved fluoroimmunoassays.

Time-resolved fluoroimmunoassay for the quantitative determination of 17a-OH-progesterone (17-OHP) in dried blood.

For the quantitative determination of immunoreactive trypsin (IRT) in dried blood.

For the quantitative determination of human biotinidase activity in dried blood. Note: Kit contains multiple packages.

For the quantitative determination of total galactose concentration in dried blood. Note: Kit contains multiple packages.

For the quantitative determination of total galactose concentration in dried blood.Note: Kit contains multiple packages.

For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration in dried blood.Note: Kit contains multiple packages.

Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens.

Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens.

Polymerase chain reaction (PCR) based assay for semiquantitative determination of TREC DNA in dried blood specimens.

A control for monitoring assay performance in isoelectric focusing techniques used for identifying hemoglobin variants.

For use with the GSP® instrument or the DELFIA® Platewash or the AutoDELFIA® automatic immunoassay system.

Vials contain Iduronate 2-sulfatase -substrate and Iduronate 2-sulfatase -internal standard, which can be used to measure the Iduronate 2-sulfatase activity with a tandem mass spectrometer (MS/MS).

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.

The MSMS Workstation is intended for use as a calculator/data processing software for the storage, retrieval, and processing of mass spectrometry data.

The Eonis Analysis Software is intended for in vitro diagnostic use for analysis of the real time PCR data generated usingthe Eonis PCR Reagent Kit for the semi-quantitative determination of TREC (signal joint T-cell receptor excision circle)and KREC (Kappa-deleting recombination excision circle), as well as the qualitative detection of the exon 7 of SMN1gene and RPP30 (Ribonuclease P/MRP Subunit P30) gene in DNA from blood specimens dried on a filter paper as an aidin screening newborns for Severe Combined Immunodeficiency (SCID), X-linked agammaglobulinemia (XLA) and SpinalMuscular Atrophy (SMA).

The Evoya Software Platform is an in vitro diagnostics modular software intended to be used together with Neonatal screening assay systems to enable workflow activities, data management, results analysis and reporting. The EVOYA Software Platform is intended to be used by trained laboratory professionals.The Evoya Software Platform is intended for in vitro diagnostic use.

Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.

Time-resolved fluoroimmunoassay for the quantitative determination of human Inhibin A.

Time-resolved fluoroimmunoassay for the quantitative determination of human alpha-fetoprotein (hAFP)

Time-resolved fluoroimmunoassay for the quantitative determination of human alphafetoprotein (hAFP)

Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).

Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3).