Clinical molecular diagnostics

Sexually transmitted infections / Chlamydia trachomatis/Ureaplasma/M.hominis / Qualitative / Real-time PCR kits; intended use requires review

Chlamydia trachomatis/Ureaplasma/M.hominis Real-TM is listed in the sexually transmitted infections PCR range. The documented assay purpose is qualitative. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Herpesvirus infections / CMV / Detection; readout requires review / Real-time PCR kits; intended use requires review

CMV Real-TM is listed in the herpesvirus infections PCR range. The documented assay purpose is detection; readout requires review. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Herpesvirus infections / CMV / Quantitative / Real-time PCR kits; intended use requires review

CMV Real-TM Quant is listed in the herpesvirus infections PCR range. The documented assay purpose is quantitative. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Herpesvirus infections / CMV/EBV/HHV6 Quant / Quantitative / Research-use real-time PCR kits

CMV/EBV/HHV6 Quant Real-TM is listed in the herpesvirus infections PCR range. The documented assay purpose is quantitative. Match the full target panel, extraction method and instrument instructions. Research use only (manufacturer listing).

Systemic and vector-borne infections / Congo Crimea / Qualitative / Real-time PCR kits; intended use requires review

Congo Crimea Real-TM is listed in the systemic and vector-borne infections PCR range. The documented assay purpose is qualitative. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Systemic and vector-borne infections / Corynebacterium diphtheriae / tox genes / Qualitative / Real-time PCR kits; intended use requires review

Corynebacterium diphtheriae / tox genes Real-TM is listed in the systemic and vector-borne infections PCR range. The documented assay purpose is qualitative. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Systemic and vector-borne infections / Coxiella burnetii / Qualitative / Real-time PCR kits; intended use requires review

Coxiella burnetii Real-TM is listed in the systemic and vector-borne infections PCR range. The documented assay purpose is qualitative. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

HIV and opportunistic infections / Cryptococcus neoformans / Detection; readout requires review / Real-time PCR kits; intended use requires review

Cryptococcus neoformans Real-TM is listed in the hiv and opportunistic infections PCR range. The documented assay purpose is detection; readout requires review. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Systemic and vector-borne infections / Dengue / Qualitative / Real-time PCR kits; intended use requires review

Dengue Real-TM is listed in the systemic and vector-borne infections PCR range. The documented assay purpose is qualitative. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Systemic and vector-borne infections / Dengue / Genotyping / Real-time PCR kits; intended use requires review

Dengue Real-TM Genotype is listed in the systemic and vector-borne infections PCR range. The documented assay purpose is genotyping. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Systemic and vector-borne infections / Ebola Zaire / Qualitative / Real-time PCR kits; intended use requires review

Ebola Zaire Real-TM is listed in the systemic and vector-borne infections PCR range. The documented assay purpose is qualitative. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Neurological infections / Enterovirus 71-Type / Qualitative / Real-time PCR kits; intended use requires review

Enterovirus 71-Type Real-TM is listed in the neurological infections PCR range. The documented assay purpose is qualitative. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Neurological infections / Enterovirus / Detection; readout requires review / Real-time PCR kits; intended use requires review

Enterovirus Real-TM is listed in the neurological infections PCR range. The documented assay purpose is detection; readout requires review. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Gastrointestinal and parasitic infections / Escherichioses Screen & Diff / Qualitative / Real-time PCR kits; intended use requires review

Escherichioses Screen & Diff Real-TM is listed in the gastrointestinal and parasitic infections PCR range. The documented assay purpose is qualitative. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Sexually transmitted infections / Configuration requires review

Detects C. trachomatis using genomic and plasmid targets. This base ordering code is distinct from bundles that include extraction reagents. The manufacturer identifies it as CE-marked IVD and lists specific FluoroCycler systems.

Human genetics / Configuration requires review

Analyzes genetically determined lactose intolerance using blood-derived DNA. It does not establish acquired lactose intolerance. The page identifies an IVD product and specifies FluoroCycler 12; the individual variants interrogated are not listed.

Respiratory infections / Configuration requires review

Separates SARS-CoV-2 detection from a channel covering four endemic human coronaviruses. Universal Internal Control 2 is supplied separately. The page lists FluoroCycler XT and mentions additional validated cyclers without identifying them.

Human genetics / Folate Metabolism Panel SNP / Detection; readout requires review / Real-time PCR kits; intended use requires review

Folate Metabolism Panel SNP is listed in the human genetics PCR range. The documented assay purpose is detection; readout requires review. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Sexually transmitted infections / Gardnerella vaginalis / Qualitative / Real-time PCR kits; intended use requires review

Gardnerella vaginalis Real-TM is listed in the sexually transmitted infections PCR range. The documented assay purpose is qualitative. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Sexually transmitted infections / Gardnerella vaginalis/Lactobacillus species / Quantitative / Real-time PCR kits; intended use requires review

Gardnerella vaginalis/Lactobacillus species Real-TM Quant is listed in the sexually transmitted infections PCR range. The documented assay purpose is quantitative. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Human genetics / Haemochromatosis / Genotyping / Real-time PCR kits; intended use requires review

Haemochromatosis Real TM is listed in the human genetics PCR range. The documented assay purpose is genotyping. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Human genetics / Haemochromatosis / Genotyping / Real-time PCR kits; intended use requires review

Haemochromatosis Real TM Melting is listed in the human genetics PCR range. The documented assay purpose is genotyping. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Viral hepatitis / HAV / Detection; readout requires review / Real-time PCR kits; intended use requires review

HAV Real-TM is listed in the viral hepatitis PCR range. The documented assay purpose is detection; readout requires review. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Viral hepatitis / HBV Genotype A, B, C, D / Genotyping / Real-time PCR kits; intended use requires review

HBV Genotype A, B, C, D Real-TM is listed in the viral hepatitis PCR range. The documented assay purpose is genotyping. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.