A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, to predic...

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

7 GUDID devices

Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, kit, nucleic acid technique (NAT)

6 GUDID devices

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of mRNA expression of the prostate cancer gene 3 (PCA3) and the gene coding for the prostate specific antigen associated with prost...

Epidermal growth factor receptor (EGFR) gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

4 GUDID devices

A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to predict or monitor the response to treatment with epidermal growth factor receptor (EGFR) inhibitors by determining the EGFR mutation status or mR...

Multiple bacterial/viral infection-associated mRNA expression IVD, control

4 GUDID devices

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of mRNA expression of specific genes associated with response to acute infection with multiple bacterial and viral pathogens...

Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)

2 GUDID devices

Her2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT)

2 GUDID devices

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of mRNA expression of the Her2/neu/erbB2 (v-erb-B2 avian erythroblastic leukaemia viral oncogene homolog 2) gene in a tumour tissue...

Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, control

2 GUDID devices

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of mRNA expression of the prostate cancer gene 3 (PCA3) and the gene coding for the prostate specific antigen associated wit...

HER2/neu/erbB2 mRNA expression IVD, probe

1 GUDID devices

A defined piece of single-stranded nucleic acid which is used to identify specific complementary-sequence nucleic acid molecules in an assay intended to be used for the qualitative and/or quantitative detection of mRNA expression of the HER2/neu/erbB2 (v-er...

Multiple gene-mediated host immune response mRNA expression IVD, kit, nucleic acid technique (NAT)

1 GUDID devices

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the mRNA expression of multiple genes associated with a response to (suspected) infection, in a clinical specimen, using a nucle...

Myeloproliferative neoplasm-associated multiple gene mutation/mRNA expression IVD, primer

1 GUDID devices

A defined piece of single-stranded nucleic acid which binds to and initiates replication of a target nucleic acid template in an assay intended to be used for the qualitative and/or quantitative determination of the gene mutation status and/or detection of ...

Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, probe

1 GUDID devices

Prostate cancer gene 3/prostate specific antigen (PCA3/PSA) mRNA expression IVD, reagent

1 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 mRNA expression of the prostate cancer gene 3 (PCA3) and the gene coding for ...

Meibomian gland manual expressor/evaluator

18 GUDID devices

A non-powered, hand-held manual ophthalmic instrument intended to be used to apply pressure to the lower eyelid to facilitate natural release and/or expression of meibomian gland secretions (meibum) for diagnostic evaluation during a routine eye examination...

A/B transferase IVD, calibrator

9 GUDID devices

A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of A and/or B transferase enzymes associated with ABO blood group expression on all cells in a clinical specimen.

Evacuated blood collection tube IVD, anticoagulant/cell preservative

4 GUDID devices

A glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum, an anticoagulant [e.g., ethylenediaminetetraacetic acid (EDTA), sodium heparin, sodium citrate, potassium oxalate], and a preservative which stabilizes cell morpholo...

Image-based pain-assessment software

2 GUDID devices

A software program designed to be used on an off-the-shelf smart device with a built-in camera (e.g., smartphone, tablet) to allow a healthcare provider/caregiver to obtain images/video of a patient to assess the patient’s level of pain; it is typically use...

Nucleic acid microarray probe chip IVD

1 GUDID devices

A collection of oligonucleotide probes intended to be used for the simultaneous hybridization of multiple amplified nucleic acid targets from a clinical specimen, for subsequent genome or transcriptome analyses [e.g., single nucleotide polymorphisms (SNPs) ...

Partial (variant) Rh(D) category VI/weak Rh(D) red cell grouping IVD, antibody, solid-phase red blood cell adherence

1 GUDID devices

One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used in testing a clinical specimen for the presence of partial (variant) Rh(D) category VI red blood cell antigens or weak expression of the Rh(D) anti...