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One of the key hallmarks to Alzheimer’s disease is the formation of neurofibrillary tangles. These are aggregates of hyperphosphorylated Tau protein, also referred to as paired helical filaments (PHF-Tau).

AMH Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analysis of Anti Müllerian Hormone (AMH) with the LUMIPULSE G system.

Qualitative detection of 15 High-Risk HPV types with simultaneous genotyping of HPV16 and 18 in one tube.

Offers fully automated processing of INNO-LIA tests from sample incubation to color development, ensuring ease of use, speed, and confidence.

Our Auto-LIA 48 offers fully automated processing for the complete range of INNO-LIA tests from sample incubation to color development, ensuring ease, speed, and confidence.

The C50 MAb defines carcinoma associated carbohydrate antigens, which are present in carcinomas of many organs and of different histopathological types.

The MUC-1 breast cancer antigen is a mucin-type glycoprotein. It is secreted from tumor cells and can be used as a serological marker of breast cancer.

The CanAg AFP EIA kit is intended for the quantitative determination of α-Fetoprotein (AFP) in human serum.

The CanAg CA15-3 EIA kit is intended for the quantitative determination of the cancer associated antigen MUC-1 (CA15-3) in serum.

The CanAg CA242 EIA kit is intended for the quantitative determination of CA242 cancer antigen in serum.

The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.

The CanAg NSE EIA kit is intended for the quantitative determination of NSE in human serum.

The CanAg PSA EIA kit is intended for the quantitative determination of Total PSA (Prostate Specific Antigen) in human serum.

The CanAg SCC EIA kit is intended for the quantitative determination of squamous cell carcinoma (SCC) antigen in serum as an aid in the management of patients with squamous cell carcinoma.

Epitope characterization has revealed five major antigenic domains of CEA, “Gold epitope 1-5”.

Colli-Pee is a device especially designed for first-void urine collection by capturing the first 20ml of a urine sample more efficiently and requiring less effort from the user.

Reagent for detection of influenza A & B virus antigens.

The combination of antibodies against hidden epitopes of PSA with antibodies against exposed epitopes may be used for the development of specific assays for detection of Free PSA.

The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring response to therapy for patients with invasive epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is further intended to be used in conjunction with either ARCHITECT CA 125 II or CanAg CA125 EIA or Lumipulse G CA125II as an aid in estimating the risk of epithelial ovarian cancer in premenopausal and postmenopausal women presenting with pelvic mass. The results must be interpreted in conjunction with other methods in accordance with standard clinical management guidelines.

Qualitative nucleic acid detection of SARS-CoV-2 (COVID-19) on naso- or oropharyngeal swabs without pre-treatment.

Fujirebio Europe NV is active in the field of confirmatory testing for infectious diseases for m

A well standardized multiparameter bead-based immunoassay for the simultaneous quantification of human β-amyloid (Aβ) forms Aβ1-42 and Aβ1-40 in plasma using xMAP® technology.

Line immunoassay for the detection of antibodies to human hepatitis C virus in human serum and plasma.

Line immunoassay for the confirmation and discrimination of antibodies to Human T-cell Lymphotrophic Virus type I (HTLV-I) and type II (HTLV-II) in human serum and plasma.

Line Immunoassay, to confirm the presence of antibodies against Treponema pallidum in human serum or plasma.

Line probe assay, intended for the simultaneous in vitro detection and identification of 18 human Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene mutations and their wild type sequence in human whole blood, dried blood spots or buccal brushes.

Multiparameter line probe assay, based on the reverse hybridization principle, for the simultaneous detection and identification of 36 cystic fibrosis-related mutations and their wild-type sequences in human whole blood, dried blood spots, and buccal brush samples.

The INNO-LiPA CFTRiage is a line probe assay, intended for the simultaneous in vitro detection and identification of 88 human Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) gene mutations and their wild type sequence in human whole blood, dried blood spots or buccal brushes.

Line probe assay for simultaneous detection of hepatitis B virus wild-type motif, lamivudine, telbivudine, emtricitabine, adefovir, and entecavir resistance-associated mutations.

Line probe assay for the simultaneous detection of wild-type motif and mutations in the basal core promoter and precore regions of the hepatitis B virus genome.

Line probe assay for the molecular typing of human leukocyte antigen (HLA) B alleles at allele group level (B*07 – B*83).

Line probe assay for the molecular typing of human leukocyte antigen (HLA) DQA1 alleles at allelic level (DQA1*01–DQA1*06).

Line probe assay for the molecular typing of human leukocyte antigen (HLA) DRB alleles at allelic level (DRB1, DRB3, DRB4, DRB5).

Line probe assay, based on the reverse hybridization principle, designed for the identification of 32 different genotypes of the human papillomavirus (HPV).

Solid-phase enzyme immunoassay for the quantitative determination of β-amyloid(1-40) in human cerebrospinal fluid (CSF).

Solid-phase enzyme immunoassay for the quantitative determination of β-amyloid(1-42) in human cerebrospinal fluid (CSF).

Enzyme immunoassay for the detection of antibodies to human hepatitis C virus (HCV) in human serum or plasma.

Enzyme immunoassay based on a unique monoclonal antibody for the quantitative determination of human placental alkaline phosphatase (hPLAP) in serum and heparinized plasma.

Solid-phase enzyme immunoassay for the quantitative determination of Tau protein in human cerebrospinal fluid (CSF).

Solid-phase enzyme immunoassay for the quantitative determination of phosphorylated Tau (Phospho-Tau(181P)) in human cerebrospinal fluid (CSF).

Objective reading of INNO-LIA® ANA strips for detection of 13 specific antibodies.

Objective reading and interpretation of INNO-LiPA® strips for detection of CFTR mutations and wild-type.

Objective reading and interpretation of the INNO-LIPA® HBV portfolio.

Objective reading and interpretation of the INNO-LiPA® strips for HPV Genotyping Extra.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) in human serum or plasma to be used in the assessment of Vitamin D sufficiency.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the fully automated quantitative measurement of AMH in specimens based a two-step immunoassay method on the LUMIPULSE G System.

For in vitro diagnostics (IVD) use with the LUMIPULSE G System for the quantitative measurement of ß2-microglobulin (ß2m) in serum, plasma and urine.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of β-amyloid in human cerebrospinal fluid.

Assayed quality control to monitor the precision of laboratory testing procedures for the analysis of β-Amyloid 1-40 and 1-42 using LUMIPULSE G Systems.

Assayed control material to monitor the precision of laboratory testing procedures for the analysis of procalcitonin on the LUMIPULSE G Systems.

For in vitro diagnostic use with the LUMIPULSE G System for the quantitative measurement of CA15-3 in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of carcinoembryonic antigen (CEA) in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic use with the LUMIPULSE G System for the quantitative measurement of estradiol (E2) in serum and plasma.

Immunoreaction cartridges for for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of free prostate specific antigen (free PSA) in human serum or plasma.

For in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of free triiodothyronine (FT3) in serum or plasma. This assay uses a mouse monoclonal antibody.

Immunoreaction cartridges set for in vitro diagnostics (IVD) use with the LUMIPULSE G System for the qualitative detection of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma.

Assayed control material to monitor the precision of laboratory testing procedures for the analysis of HBcrAg using LUMIPULSE G Systems.

Immunoreaction cartridges set for in vitro diagnostics (IVD) use with the LUMIPULSE G System for the qualitative detection of hepatitis B e antigen (HBeAg) in human serum or plasma. This product is indicated as an aid in the diagnosis and monitoring of hepatitis B viral infection and for professional use only.

Immunoreaction cartridges for in vitro diagnostics (IVD) use with the LUMIPULSE G System for the quantitative measurement of HE4 in human serum or plasma (sodium haparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for qualitative detection of antibody to HTLV-I and HTLV-II in human serum or plasma for screening of HTLV-I/II viral infection.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of luteinizing hormone (LH) in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of myoglobin in human serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of pepsinogen I in specimens based on CLEIA technology by two-step sandwich immunoassay method on the LUMIPULSE G system.

Assayed control to monitor the precision of laboratory testing procedures for the analysis of Pepsinogen I and Pepsinogen II on the LUMIPULSE G Systems.

Assayed control serum to monitor the precision of laboratory testing procedures for the analysis of PIVKA-II and KL-6 using LUMIPULSE Systems.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of Pro-gastrin-releasing peptide [ProGRP (31-98)] in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of prostate specific antigen (PSA) in serum or plasma.

Assayed quality control to monitor the precision of laboratory testing procedures for the analysis of pTau using LUMIPULSE G Systems.

Immunoreaction cartridges for in vitro diagnostic use with the LUMIPULSE G instruments for the quantitative measurement of squamous cell carcinoma (SCC) antigen in human serum or plasma samples as an aid in the management of patients with squamous cell carcinoma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of anti-thyroglobulin antibodies (TgAb) in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of total Tau in human cerebrospinal fluid (CSF).

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the qualitative measurement of treponema pallidum (TP) antibodies (IgG and IgM) in serum or plasma. Includes calibrators.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of triiodothyronine (T3) in serum or plasma.

Immunoreaction cartridges for in vitro diagnostic (IVD) use with the LUMIPULSE G System for the quantitative measurement of thyroid-stimulating hormone (TSH) in serum or plasma.

Lung Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analysis of CYFRA and ProGRP with the LUMIPULSE G system.

The glycolytic enzyme enolase (2-phospho-D-glycerate hydrolase, EC 4.2.1.11) exists as several dimeric isoenzymes (αα,αβ, αγ, ββ and γγ).

Power-Gene 9600 Plus adopts Ferrotec specially-made Peltier, advanced fiber optic technology, new global wide-range power supply, the unique patented block dissipation technology and bottom detection mode, which provides better heating/cooling rate, temperature accuracy, uniformity and stability.

Assayed control to monitor the performance of laboratory testing procedures for the analysis of Anti-HIV 1, IgG Anti-HBc, Anti-HTLV Ig, Anti-HCV IgG HBsAg, Anti-Treponema pallidum IgG analytes in human serum and plasma.

Fully automated processing of INNO-LIA® tests from sample pipetting to strip reading and LiRAS® interpretation**, transforming tedious manual work into a completely automated throughput of high testing volumes, ensuring ease of use, chain of custody (Pos ID), and consistent performance

Particle-agglutination Rheumatoid factor test.

Human immunodeficiency virus types 1 and 2 (HIV-1 and HIV-2) antibody test.

Particle-agglutination test for the detection of antibodies to Mycoplasma pneumoniae.

Product designed for use on OLYMPUS PK-7200/7300 instruments. Particle-agglutination test for the detection of antibodies to Treponema Pallidum.

Assayed quality control serum to monitor the precision of laboratory measurement procedures.

D-Dimer is a fibrin degradation product, a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. D-dimer concentration may be determined in a test to help diagnose thrombosis.

Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analytes listed in the lot specific assigned values sheet.