A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens

A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gas-trointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gas-trointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.

Multiplex Nucleic Acid-Based Assay System (PCH)

Device description: The gastrointestinal panel multiplex nucleic acid-based assay system is a diagnostic tool that detects multiple gastrointestinal pathogens (bacteria, viruses, parasites) from stool samples using nucleic acid amplification methods like PCR. It allows for simultaneous detection of various pathogens, offering faster and more accurate results compared to traditional methods. This system is especially useful in diagnosing unexplained gastrointestinal infections and helps guide effective treatment.

Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System (PCI)

Device description: A gastrointestinal bacterial panel multiplex nucleic acid-based assay system is a diagnostic tool used to detect a range of bacterial pathogens that cause gastrointestinal (GI) infections. This system uses nucleic acid-based testing methods, such as polymerase chain reaction (PCR), to identify bacterial DNA or RNA from a patient sample (like stool) in a single test, targeting multiple bacterial pathogens at once. It’s called “multiplex” because it can detect genetic material from several bacteria’

Reagents for detection of norovirus nucleic acid (PIQ)

Device description: Norovirus GI/GII is a real-time RT-PCR in vitro diagnostic test for qualitative detection and differentiation of norovirus genogroup I and II RNA in human stool specimens. The test uses two separate instruments for sample preparation, RNA extraction, and amplification/real-time detection. An internal control RNA is added to each sample before extraction, and the Applied Biosystems 7500 Fast Dx System is used for amplification/real-time detection. The RIDA GENE Norovirus GI/GII assay kit contains enough reagents for 100 reactions and is stored at -20°C.

• Reproducibility
• Precision
• Limit of Detection
• Cross-reactivity
• Analytical reactivity
• Interfering substances

The same is applicable for CE Marking under IVDR also.

Required for 510k submission and IVDR CE Marking