Clinical molecular diagnostics

Gastrointestinal and parasitic infections / A.I.I. Screen / Qualitative / Real-time PCR kits; intended use requires review

A.I.I. Screen 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.

Gastrointestinal and parasitic infections / Aerobic complex / Quantitative / Real-time PCR kits; intended use requires review

Aerobic complex Real-TM Quant is listed in the gastrointestinal and parasitic 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 / Configuration requires review

Manufacturer-listed molecular assay for C. difficile detection. The assay identity is distinct from the separately referenced external controls. Intended-use status, specimen restrictions and required reader configuration are unknown from the visible product HTML.

Systemic and vector-borne infections / Configuration requires review

Manufacturer-listed molecular assay for Plasmodium detection. The visible page does not establish species differentiation, specimen compatibility or required instrument configuration. Intended-use regulatory status is unknown from this HTML source.

Respiratory infections / ARVI Plus / Detection; readout requires review / Real-time PCR kits; intended use requires review

ARVI Plus 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 / ARVI Screen / Detection; readout requires review / Real-time PCR kits; intended use requires review

ARVI Screen 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 / Avian A Screening & H5N1Typing FRT / Genotyping / Real-time PCR kits; intended use requires review

Avian A Screening & H5N1Typing FRT is listed in the respiratory 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.

Human genetics / AZF System Y-chromosome / Detection; readout requires review / Real-time PCR kits; intended use requires review

AZF System Y-chromosome 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.

Antimicrobial resistance / Bac Multi Resist / Detection; readout requires review / Real-time PCR kits; intended use requires review

Bac Multi Resist 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 / Bac Multi Screen / Detection; readout requires review / Real-time PCR kits; intended use requires review

Bac Multi Screen 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.

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

Bacillus anthracis 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.

Sexually transmitted infections / Bacterial Vaginosis / Quantitative / Real-time PCR kits; intended use requires review

Bacterial Vaginosis 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.

Respiratory infections / Bordetella pertussis/B.parapertussis/B.bronchiseptica / Detection; readout requires review / Real-time PCR kits; intended use requires review

Bordetella pertussis/B.parapertussis/B.bronchiseptica 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.

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

Borrelia burgdorferi 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 / Borrelia miyamotoi / Qualitative / Real-time PCR kits; intended use requires review

Borrelia miyamotoi 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 / Brucella / Qualitative / Real-time PCR kits; intended use requires review

Brucella 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.

Sexually transmitted infections / Candida albicans / Qualitative / Real-time PCR kits; intended use requires review

Candida albicans 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 / Candida albicans/Candida glabrata/Candida krusei / Qualitative / Real-time PCR kits; intended use requires review

Candida albicans/Candida glabrata/Candida krusei 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 / Candidosis / Quantitative / Real-time PCR kits; intended use requires review

Candidosis 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 / Cardio Thrombophilia Panel SNP / Detection; readout requires review / Real-time PCR kits; intended use requires review

Cardio Thrombophilia 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 / Chlamydia trachomatis /Ureaplasma/ M.genitalium/M.hominis / Qualitative / Real-time PCR kits; intended use requires review

Chlamydia trachomatis /Ureaplasma/ M.genitalium/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.

Sexually transmitted infections / Chlamydia trachomatis A,B,C Typing / Qualitative / Real-time PCR kits; intended use requires review

Chlamydia trachomatis A,B,C Typing 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 / Chlamydia trachomatis / Detection; readout requires review / Real-time PCR kits; intended use requires review

Chlamydia 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 / Chlamydia trachomatis/Ureaplasma/M.genitalium / Qualitative / Real-time PCR kits; intended use requires review

Chlamydia trachomatis/Ureaplasma/M.genitalium 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.