Search

30 matching records for IVD 2.

GMDN Terms#

Assay development analyte-specific reagent IVD

4,631 GUDID devices

An antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological...

Nucleic acid hybridization detection IVD, reagent

830 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay intended to be used for the generic detection of nucleic acid (e.g., DNA, RNA) probes hybridized to their target nucleotide sequences in a clin...

Faecal occult blood IVD, reagent

786 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative screening of stool (faeces) for occult blood (haemoglobin).

Laboratory instrument/analyser application software IVD

478 GUDID devices

A software program intended to be used with an in vitro diagnostic instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser), or a data management device connected to the IVD instrument/analyser, to facilitate user-controlle...

Multiple Salmonella species culture isolate antigen IVD, reagent

442 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from one or multiple species of Salmonella bacteria isolated by cult...

Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

401 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.

DNA-based tissue typing IVD, reagent

232 GUDID devices

A reagent which is intended to be used together with a parent IVD to perform a specific function in an assay that is used to evaluate a clinical specimen to diagnose or predict donor and recipient tissue compatibility based on one or multiple genetic marker...

Glucose IVD, reagent

185 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of glucose in a clinical specimen.

Immunohistochemistry antibody detection IVD, reagent

142 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an immunohistochemistry assay that is used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers...

Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

122 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens in a clinical ...

Glycated haemoglobin (HbA1c) IVD, reagent

111 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of glycated haemoglobin (HbA1c), also known as glycosylated haemoglobin in a cli...

Multiple biogenic amine neurotransmitter IVD, reagent

93 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple biogenic amine neurotransmitters [e.g., catecholamines (dopamine, no...

Total protein IVD, reagent

78 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total protein in a clinical specimen.

Uric acid IVD, reagent

78 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of uric acid in a clinical specimen.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, reagent

75 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes de...

Multiple CD cell marker IVD, reagent

71 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple cluster of differentiation (CD) cell markers in a clinical specimen,...

Western equine encephalitis (WEE) virus total antibody IVD, reagent

70 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to Western equine encephalitis (WEE) virus in a clinical spe...

Triglyceride IVD, reagent

67 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of triglycerides in a clinical specimen.

Total cholesterol lipid IVD, reagent

63 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total cholesterol lipid in a clinical specimen.

Multiple Shigella species culture isolate antigen IVD, reagent

62 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of antigens from one or multiple species of Shigella bacteria isolated by cultur...

Alanine aminotransferase (ALT) IVD, reagent

61 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of alanine aminotransferase (ALT) in a clinical specimen.

Plasma protein IVD, reagent

59 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of plasma proteins in a clinical specimen.

Semliki Forest virus total antibody IVD, reagent

58 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of total antibodies to Semliki Forest virus in a clinical specimen.

Inorganic phosphate (PO43-) IVD, reagent

55 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of inorganic phosphate (PO43-) [phosphorus] in a clinical specimen.

Multiple coagulation factor IVD, reagent

52 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or the...

Gamma-glutamyltransferase (GGT) IVD, reagent

51 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of gamma glutamyltransferase (GGT) in a clinical specimen.

Platelet aggregation study IVD, reagent

51 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, w...

Urea IVD, reagent

50 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical...

Beta-haemolytic Streptococcus serological grouping IVD, reagent

48 GUDID devices

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay used to determine the serological group (or Lancefield group) of beta-haemolytic streptococci isolated from a clinical specimen by culture.