Clinical molecular diagnostics

Human papillomavirus / HPV Genotypes 14 / Quantitative / Real-time PCR kits; intended use requires review

HPV Genotypes 14 Real-TM Quant is listed in the human papillomavirus PCR range. The documented assay purpose is quantitative, genotyping. Match the full target panel, extraction method and instrument instructions. Not established by the public listing; check current IFU and regional availability.

Human papillomavirus / HPV Genotypes 21 / Detection; readout requires review / Real-time PCR kits; intended use requires review

HPV Genotypes 21 Real-TM Quant is listed in the human papillomavirus 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.

Human papillomavirus / HPV High Risk Screen / Quantitative / Real-time PCR kits; intended use requires review

HPV High Risk Screen Real-TM Quant is listed in the human papillomavirus 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 papillomavirus / HPV High Risk Screen / Quantitative / Real-time PCR kits; intended use requires review

HPV High Risk Screen Real-TM Quant 2X is listed in the human papillomavirus 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 / HSV I/II / Qualitative / Real-time PCR kits; intended use requires review

HSV I/II 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.

Herpesvirus infections / HSV I/II Typing / Qualitative / Real-time PCR kits; intended use requires review

HSV I/II Typing 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.

Human genetics / IL28B rs17/rs60 / Genotyping / Real-time PCR kits; intended use requires review

IL28B rs17/rs60 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.

Respiratory infections / Influenza A H1N1 & H3N2 / Detection; readout requires review / Real-time PCR kits; intended use requires review

Influenza A H1N1 & H3N2 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.

Respiratory infections / Influenza A, B / Detection; readout requires review / Real-time PCR kits; intended use requires review

Influenza A, B 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.

Respiratory infections / Influenza virus A H5 H7 H9 Typing FRT / Qualitative / Real-time PCR kits; intended use requires review

Influenza virus A H5 H7 H9 Typing FRT 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.

Neurological infections / JCV/BKV Virus / Quantitative / Real-time PCR kits; intended use requires review

JCV/BKV Virus Real-TM Quant is listed in the neurological 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 / Legionella pneumophila / Quantitative / Real-time PCR kits; intended use requires review

Legionella pneumophila Real-TM is listed in the respiratory 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.

Gastrointestinal and parasitic infections / Leishmania spp. / Qualitative / Real-time PCR kits; intended use requires review

Leishmania spp. 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.

Systemic and vector-borne infections / Leptospira 16s RNA / Qualitative / Real-time PCR kits; intended use requires review

Leptospira 16s RNA 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 / Listeria monocytogenes / Detection; readout requires review / Real-time PCR kits; intended use requires review

Listeria monocytogenes Real-TM Quant 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.

Antimicrobial resistance / MDR KPC/OXA / Detection; readout requires review / Real-time PCR kits; intended use requires review

MDR KPC/OXA Real-TM is listed in the antimicrobial resistance 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.

Antimicrobial resistance / MDR MBL (VIM,IMP,NDM) / Detection; readout requires review / Real-time PCR kits; intended use requires review

MDR MBL (VIM,IMP,NDM) Real-TM is listed in the antimicrobial resistance 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 / MERS-SARS CoV / Detection; readout requires review / Real-time PCR kits; intended use requires review

MERS-SARS CoV 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.

Antimicrobial resistance / MRSA Quant / Quantitative / Real-time PCR kits; intended use requires review

MRSA Quant Real-TM is listed in the antimicrobial resistance 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.

Tuberculosis / MTB Diff / Qualitative / Real-time PCR kits; intended use requires review

MTB Diff Real-TM is listed in the tuberculosis 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.

Tuberculosis / MTB MDR Resistance / Detection; readout requires review / Real-time PCR kits; intended use requires review

MTB MDR Resistance Real-TM is listed in the tuberculosis 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.

Tuberculosis / MTB / Detection; readout requires review / Real-time PCR kits; intended use requires review

MTB Real-TM is listed in the tuberculosis 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 / Mycoplasma genitalium / Detection; readout requires review / Real-time PCR kits; intended use requires review

Mycoplasma genitalium 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 / Mycoplasma hominis / Detection; readout requires review / Real-time PCR kits; intended use requires review

Mycoplasma hominis 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.