Clinical molecular diagnostics

Gastrointestinal and parasitic infections / Rotavirus/Norovirus/Astrovirus / Qualitative / Real-time PCR kits; intended use requires review

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

TORCH infections / Rubella / Detection; readout requires review / Real-time PCR kits; intended use requires review

Rubella Real-TM Qual is listed in the torch 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.

Respiratory infections / SARS-Cov-2 / Qualitative / Real-time PCR kits; intended use requires review

SARS-Cov-2 Real-TM is listed in the respiratory 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.

Respiratory infections / SARS-CoV-2/Influenza A/B multiplex / Detection; readout requires review / Real-time PCR kits; intended use requires review

SARS-CoV-2/Influenza A/B multiplex Real-TM is listed in the respiratory 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 / Shigella/Salmonella/Campylobacter / Detection; readout requires review / Real-time PCR kits; intended use requires review

Shigella/Salmonella/Campylobacter Real-TM is listed in the gastrointestinal and parasitic 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 / Strep B / Quantitative / Real-time PCR kits; intended use requires review

Strep B Real-TM Quant is listed in the systemic and vector-borne 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.

Systemic and vector-borne infections / Streptococcus pyogenes / Quantitative / Real-time PCR kits; intended use requires review

Streptococcus pyogenes Real-TM Quant is listed in the systemic and vector-borne 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.

Respiratory infections / Swine Influenza Virus A/H1 / Qualitative / Real-time PCR kits; intended use requires review

Swine Influenza Virus A/H1 Real-TM is listed in the respiratory 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 / T. vaginalis/N. gonorrhoeae / Qualitative / Real-time PCR kits; intended use requires review

T. vaginalis/N. gonorrhoeae 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.

Systemic and vector-borne infections / TBEV, B.burgdorferi sl, A.phagocytophilum, E.chaffeensis / E.muris / Qualitative / Real-time PCR kits; intended use requires review

TBEV, B.burgdorferi sl, A.phagocytophilum, E.chaffeensis / E.muris 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.

TORCH infections / Toxoplasma gondii / Detection; readout requires review / Real-time PCR kits; intended use requires review

Toxoplasma gondii Real-TM is listed in the torch 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.

Sexually transmitted infections / Treponema pallidum / Qualitative / Real-time PCR kits; intended use requires review

Treponema pallidum 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 / Trichomonas vaginalis /N.gonorrhoeae /C.trachomatis / Detection; readout requires review / Real-time PCR kits; intended use requires review

Trichomonas vaginalis /N.gonorrhoeae /C.trachomatis Real-TM is listed in the sexually transmitted 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.

Sexually transmitted infections / Trichomonas vaginalis / Detection; readout requires review / Real-time PCR kits; intended use requires review

Trichomonas vaginalis Real-TM is listed in the sexually transmitted 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.

Sexually transmitted infections / Ureaplasma parvum/Ur. urealyticum/M. hominis / Quantitative / Real-time PCR kits; intended use requires review

Ureaplasma parvum/Ur. urealyticum/M. hominis 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.

Sexually transmitted infections / Ureaplasma species / Detection; readout requires review / Real-time PCR kits; intended use requires review

Ureaplasma species Real-TM is listed in the sexually transmitted 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 / Vibrio cholerae / Qualitative / Real-time PCR kits; intended use requires review

Vibrio cholerae 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.

Herpesvirus infections / VZV / Qualitative / Real-time PCR kits; intended use requires review

VZV Real-TM is listed in the herpesvirus 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 / West Nile Virus / Qualitative / Real-time PCR kits; intended use requires review

West Nile Virus 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 / Yersinia pestis / Qualitative / Real-time PCR kits; intended use requires review

Yersinia pestis 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 / Zika Virus / Qualitative / Real-time PCR kits; intended use requires review

Zika Virus 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.