The CE marked AmpFire® HPV High Risk Genotyping kit is intended for fast, simple, and accurate qualitative detection and identification of 15 High-Risk HPV genotypes 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, and 68.
Qnostics’ SARS-CoV-2(SCV2) Q Controls are single use positive controls intended to support the validation, verification and performance monitoring of molecular assays used in the testing of SARS-CoV-2 (COVID-19). Qnostics controls contain the entire SARS-CoV-2 genome meaning they are compatible with the majority of commercial and in-house assays. As whole pathogen controls they target the whole viral genome, including CDC and WHO consensus sequences.
Healgen Strip for Urinalysis is in vitro diagnostic test device that use reagents for qualitative and semi-quantitative urinalysis. The strips are for professional use only and intended for use to detect conditions indicating possible diabetes, metabolic abnormalities, liver diseases, kidney function, and urinary tract infections. The test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.
The AMPLIRUN TOTAL SARS-COV-2 CONTROL comprises inactivated SARS-CoV-2 cells formulated in viral transport medium to validate and control molecular analyses for the diagnosis of COVID-19. It enables external quality control for nucleic acids detection and validation of the complete analytical process: extraction & amplification.
YHLO’s IgG and IgM combined detection is a good supplementary diagnostic tool to PCR, which can identify who are immune to COVID-19 after infection in mass population and its titer change can be used to monitor treatment of COVID-19 patients. Together with iFlash fully automation system, manual work and aerosol contamination risk can be reduced. The assays are CE marked, FDA EUA application accepted and legal export qualification obtained.
The COVID-19 IgG/IgM Detection Kit (Colloidal Gold) requires just one sample drop of blood, serum or plasma to deliver results in 10 minutes. The test card contains novel coronavirus antigen and colloidal gold labeled antibody used in colloidal gold labeling. The test has CE certificate and has been tested to produce a high level of accuracy.
The UroVysion Bladder Cancer Kit is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. It delivers definitive results in atypical cytology cases with equivocal or negative cystoscopy and is the only urine-based molecular test approved by the FDA to aid bladder cancer surveillance and assist with diagnosis.
The newly-launched Epithod 616 CRP Test Kit is for in vitro diagnostic (IVD) use to determine C-reactive protein (CRP) quantitatively in serum/plasma, or whole blood from a human. It provides information for the diagnosis, treatment and monitoring of inflammatory diseases and bring reliable and cost-effective results to professionals.
The Novel Coronavirus (2019-nCoV) IgG/IgM Test Kit (Colloidal Gold) has been developed for the identification of SARS-CoV-2, the virus that causes COVID-19. The test uses low sample volume of whole blood, serum and plasma to deliver rapid results within 15 minutes in just three steps.
The UniTranz-RT is a sterile kit, complete with a 3ml vial of Universal Transport Medium and an ultrafine PurFlock Ultra swab. The kit meets all CDC guidelines and protocol for COVID-19 testing, with its patented fibers guaranteeing maximum cell collection and its ultrafine tip making it perfect for nasopharyngeal sampling.
The EUROArray STI provides parallel direct detection of up to 11 sexually transmitted pathogens in one reaction. It is particularly suitable for detecting pathogens that are difficult or impossible to cultivate. The combined detection is useful for clarifying ambiguous clinical findings, identifying asymptomatic infections, and identifying multiple infections with different sexually transmitted pathogens. Early diagnosis of STI can help to prevent infertility and miscarriages. The procedure is easy to perform and includes fully automated evaluation and interpretation of results.