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The TSHL method is an in vitro diagnostic test for the quantitative measurement of Thyroid Stimulating Hormone (TSH, thyrotropin) in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of TSH are used in the diagnosis and monitoring of thyroid disease. The FT4L method is an in vitro diagnostic test for the quantitative measurement of Free Thyroxine in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of free thyroxine are used in the diagnosis and monitoring of thyroid disease.

The Dimension® LOCI® Thyroid Stimulating Hormone Flex® reagent cartridge (TSHL) and Dimension® LOCI® Free Thyroxine Flex® reagent cartridge (FT4L) assays were cleared under K081074 and K073604, respectively. The components of the cleared assays were modified to reduce biotin interference. The modified Assays are comprised of the following components: Dimension® LOCI® Thyroid Stimulating Hormone Flex® reagent cartridge (TSHL): prepackaged liquid reagents in a plastic eight-well cartridge. Wells 1-2 contain Biotinylated TSH antibody (7.5 µg/mL mouse monoclonal), wells 3-4 contain TSH antibody coated Chemibeads (200 µg/mL mouse monoclonal), and wells 5-6 contain Streptavidin Sensibeads (1400 µg/mL recombinant E. coli). Wells 1-6 contain buffers, stabilizers and preservatives. Wells 7-8 are empty. Dimension® LOCI® Free Thyroxine Flex® reagent cartridge (FT4L): prepackaged liquid reagents in a plastic eight-well cartridge. Wells 1-2 contain Streptavidin Sensibeads (225 µg/mL recombinant E. coli), wells 3-4 contain T3 Chemibeads (200 µg/mL), and wells 5-6 contain FT4 Biotinylated antibody (50 ng/mL mouse monoclonal). Wells 1-6 contain buffers, stabilizers and preservatives. Wells 7-8 are empty. Test Principle: Both devices use a homogeneous chemiluminescent immunoassay based on LOCI® technology. For TSHL, it's a sandwich immunoassay where sample is incubated with biotinylated antibody and Chemibeads to form bead-TSH-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination at 680 nm generates singlet oxygen from Sensibeads which diffuses into Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of TSH concentration. For FT4L, it's a sequential immunoassay where sample is incubated with biotinylated antibody. T3 Chemibeads are added and form bead/biotinylated antibody immunocomplexes with the non-saturated fraction of the biotinylated antibody. Sensibeads are then added and bind to the biotin to form bead pair immunocomplexes. Illumination at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is an inverse function of FT4 concentration.

The Maverick Test Panel A0.B0 is an immunoassay for the quantitative determination of human thyroid stimulating hormone (thyrotropin, TSH) in human serum and K2EDTA plasma on the Maverick Diagnostic System TC1000. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The Maverick Diagnostic System TC1000 is an automated immunoassay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.

The Maverick Diagnostic System TC1000 is an automated immunoassay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology. The Maverick Test Panel A0.B0 is an immunoassay for the quantitative determination of human thyroid stimulating hormone (thyrotropin, TSH) in human serum and K2EDTA plasma on the Maverick Diagnostic System TC1000.

The ADVIA Centaur® TSH3-Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP system. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

This assay is a third-generation assay that employs anti-FITC monoclonal antibody covalently bound to paramagnetic particles, an FITC-labeled anti-TSH capture mouse monoclonal antibody, and a tracer consisting of a proprietary acridinium ester and an anti-TSH mouse monoclonal antibody conjugated to bovine serum albumin (BSA) for chemiluminescent detection.

The Atellica® CI Analyzer is an automated, integrated system in vitro diagnostic tests on clinical specimens. The system is intended for the qualitative analysis of various body fluids, using photometry, turbidimetric, chemiluminescent, and integrated ionselective electrode technology for clinical use. The Atellica® IM Thyroid Stimulating Hormone 3-Ultra (TSH3-UL) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Atellica® CI Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The Atellica® CH Albumin BCP (AlbP) assay is for in vitro diagnostic use in the quantitative measurement of albumin in human serum and plasma (lithium heparin, potassum EDTA) using the Atellica® CI Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.

The Atellica® CI Analyzer is an automated, integrated system designed to perform in vitro diagnostic tests on clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ionselective electrode technology for clinical use. The Atellica CI Analyzer with Atellica® Rack Handler supports both clinical chemistry (CH) and Immunoassay (IM) features and contains all the necessary hardware, electronics, and software to automatically process samples and generate results, including sample and reagent dispensing, mixing, and incubating. The Atellica IM TSH3-UL assay is a third-generation assay that employs anti-FITC monoclonal antibody covalently bound to paramagnetic particles, an FITC-labeled anti-TSH capture mouse monoclonal antibody, and a tracer consisting of a proprietary acridinium ester and an anti-TSH mouse monoclonal antibody conjugated to bovine serum albumin (BSA) for chemiluminescent detection The Atellica CH Albumin BCP (AlbP) assay is an adaptation of the bromocresol purple dy-e binding method reported by Carter and Louderback et al. In the Atellica CH AlbP assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at 596/694 nm coenzyme NAD+ functions only with the bacterial (Leuconostoc mesenteroides) enzyme employed in the assay.

The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. The DxI 9000 Access Immunoassay Analyzer is an in vitro diagnostic device used for the quantitative, semiquantitative, or qualitative determination of various analyte concentrations found in human body fluids.

Access TSH (3rd IS) assay is a two-site immunoenzymatic ("sandwich") assay. The Access TSH (3rd IS) reagent kit is in a liquid ready-to-use format designed for optimal performance on Beckman Coulter's immunoassay analyzers. Each reagent kit contains two reagent packs. Other items needed to run the assay include substrate, calibrators and wash buffer. The Dxl 9000 Access Immunoassay Analyzer is a fully automated, continuous, random-access sample processing and analysis instrument. The Dxl 9000 Access Immunoassay Analyzer uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.

Immunoassay for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

The Elecsys TSH immunoassay makes use of a sandwich test principle using monoclonal antibodies specifically directed against human TSH. The antibodies labeled with ruthenium complex) consist of a chimeric construct from human and mouse specific components. The Elecsys TSH immunoassay is used for the in vitro quantitative determination of thyroid stimulating hormone in human serum and plasma. It is intended for use on the cobas e immunoassay analyzers.

AFIAS TSH-SP, for use in conjunction with the AFIAS-6/SP Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in serum, sodium-heparinized plasma samples. The test system is intended for use as an aid in the diagnosis of thyroid or pituitary disorders. AFIAS-6/SP Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Pointof-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in serum or plasma samples. AFIAS TSH-VB, for use in conjunction with the AFIAS-6/VB Analyzer, is an immunofluorometric test system intended for in vitro diagnostic use at clinical laboratories and Point-of-Care (POC) sites for the quantitative measurement of thyroid stimulating hormone (TSH) levels in sodium-heparinized or EDTA venous whole blood samples. The test system is intended for the monitoring of TSH levels in euthyroid and hypothyroid individuals. AFIAS-6/VB Analyzer is a fluorescence-scanning instrument for in vitro diagnostic use at clinical laboratories and Pointof-Care (POC) sites in conjunction with various in vitro diagnostic AFIAS immunoassays for measuring the concentration of designated analytes in venous whole blood samples.

AFIAS TSH-SP as well as AFIAS TSH-VB Test Cartridge is a plastic structure molded in the form of a disposable, self-contained, unitized device which houses the 'lyophilized detection buffer', the 'diluent i.e. reconstitution buffer' as well as the 'test strip'; all of which are integral components of the test. The test cartridge is an elongated structure having 140 mm length. 17 mm width and 17 mm height. 'AFIAS TSH-SP ID Chip' as well as 'AFIAS TSH-VB ID Chip' is a flat, rectangular device with its main body measuring 24 mm × 20 mm × 3 mm. Another rectangular portion measuring 12 mm × 10 mm × 2 mm protrudes out from the apical side of the main body. The ID Chip is an electronic memory device fitted into a plastic matrix. Lot-specific 'ID Chip' is an integral component of the test. AFIAS-6/SP as well as AFIAS-6/VB analyzer is a compact, bench-top, automated, fluorometric analyzer measuring 42 cm (L) x 33.6 cm (W) x 29.3 cm (H). AFIAS-6 weighs 15.1 kg. Either analyzer is a flourometer instrument of closed-system analyzer type.

For in vitro diagnostic use. Lumipulse G TSH-III is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of thyroid stimulation hormone (TSH) in human serum on the LUMIPULSE G System. Lumipulse GTSHIII is to be used as an aid in the diagnosis of thyroid or pituitary disorders.

Lumipulse GTSH-III is an assay system, including a set of immunoassay reagents, for the quantitative measurement of TSH in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System. TSH in specimens specifically binds to anti-human TSH monoclonal antibody (mouse) on the particles, and antigen-antibody immunocomplexes are formed. The particles are washed and rinsed to remove unbound materials. Alkaline phosphatase (ALP: calf)-labeled anti-human TSH monoclonal antibody (mouse) specifically binds to TSH of the immunocomplexes on the particles, and additional immunocomplexes are formed. The particles are washed and rinsed to remove unbound materials. Substrate Solution is added and mixed with the particles. AMPPD contained in the Substrate Solution is dephosphorylated by the catalysis of ALP indirectly conjugated to particles. Luminescence (at a maximum wavelength of 477 nm) is generated by the cleavage reaction of dephosphorylated AMPPD. The luminescent signal reflects the amount of TSH.

The MAGLUMI 2000 TSH assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH) in human serum. The measurement of TSH is used in the diagnosis of thyroid disorders. The MAGLUMI 2000 Immunoassay system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical serum specimens. The MAGLUMI 2000 Immunoassay system's assay application utilizes chemiluminescents technology for clinical use.

The MAGLUMI 2000 system is a floor model, fully automated instrument system that utilizes chemiluminescent technology and uses pre-packaged reagent packs to measure a variety of analytes in human body fluids. It is controlled through a combination of custom and off-the-shelf software. MAGLUMI 2000 TSH kit consists of the following reagents: Magnetic Microbeads- coated with anti-TSH monoclonal antibody, phosphate buffer, NaN3(<0.1%) and ProClin® 300; Calibrator Low-TSH antigen (human origin), phosphate buffer, bovine serum, NaN3(<0.1%) and ProClin® 300; Calibrator High- TSH antigen (human origin), phosphate buffer, bovine serum, NaN3(<0.1%) and ProClin® 300; Buffer- tris buffer, HAMA Blocker, BSA, NaN3(<0.1%) and ProClin® 300; ABEI Label- labeled with anti-TSH monoclonal antibody (mouse), tris buffer, containing BSA, NaN3(<0.1%) and ProClin® 300; Control 1- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300; Control 2- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300; Control 3- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300.

cobas e 801 immunoassay analyzer is intended for the in-vitro determination of analytes in body fluids. Elecsys TSH immunoasay is intended for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid or pituitary disorders. The Elecsys TSH immunoassay is an electrochemiluminescence immunoasay 'ECLIA', which is intended for use on the cobas e immunoassay analyzers.

The cobas e 801 immunoassay analyzer is a fully automated, software controlled analyzer system for in vitro determination of analytes in human body fluids. It is part of the cobas 8000 modular analyzer series cleared under K100853. It uses electrochemiluminescent technology for signal generation and measurement.