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.

The TriNEST™ microplate incubator and shaker is intended for use in laboratories where incubation and shaking of microplates is needed.

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

VICTOR2 D will primarly be used for measuring test kits supplied by Wallac especially for neonatal tests. Secondly VICTOR2 D can also be used for other measurements of TRF and prompt fluorescence. The user is a laboratory running screening on newborns or a general clinical chemistry lab running different hormones on blood samples.

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.

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 contains multiple packages.

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

For the quantitative determination of galactose and galactose-1-phosphate in dried blood. Note: Kit contains multiple packages.

The product is to be used together with the NeoGram Amino Acids and Acylcarnitines Tandem Mass Spectrometry kit, and is intended for the measurement of amino acid, free carnitine, and acylcarnitine concentrations from newborn heel prick blood samples dried on filter paper.

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

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.

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).

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.

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.

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 Creatine Kinase -MM (CK-MM) concentration in dried blood.Note: Kit contains multiple packages.

Specimen Gate® PatientCare™ is intended for management of the follow-up workflow of a screening 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® 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.

Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood.

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

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

For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.

For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.

For the quantitative determination of 17α-OH-progesterone (17-OHP) in dried blood.

Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood.

Time-resolved fluoroimmunoassay for the quantitative determination of human thyrotropin (thyroid stimulating hormone - hTSH) in dried blood.

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 thyroxine (T4) in dried blood.

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

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