Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - 62773 - general specimen collection kit ivd, transport medium - the xpert specimen collection kits are intended to collect, preserve, and transport specimens collected in a clinical setting to the laboratory for use with xpert ct/ng or xpert tv.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - 48374 - hepatitis c virus nucleic acid ivd, kit, nucleic acid technique (nat) - the xpert hcv vl fingerstick (fs) assay is an in vitro reverse transcription polymerase chain reaction (rt-pcr) assay for the detection and quantification of hepatitis c virus (hcv) rna in human capillary fingerstick edta whole blood and venous edta whole blood from hcv-infected individuals using the automated genexpert? instrument systems. the xpert hcv vl fs assay is intended as an aid in the initial diagnosis in individuals at high risk of hcv infection or in anti-hcv positive individuals. the xpert hcv vl fingerstick (fs) assay is an in vitro reverse transcription polymerase chain reaction (rt-pcr) assay for the detection and quantification of hepatitis c virus (hcv) rna in human capillary fingerstick edta whole blood and venous edta whole blood from hcv-infected individuals using the automated genexpert? instrument systems. the xpert hcv vl fs assay is intended for use as an aid in the initial diagnosis in individuals at high risk of hcv infection or in anti-hcv positive individuals. the xpert hcv vl fs assay is intended for use as an aid in the management of hcv infected patients undergoing antiviral therapy. the xpert hcv vl fs assay is intended to be used by laboratory professionals or specifically-trained healthcare workers

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct772 - severe acute respiratory syndrome-associated coronavirus ivds - assays intended to be used in the diagnosis of respiratory viral infections due severe acute respiratory syndrome-associated coronavirus (sars-cov).

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - 48374 - hepatitis c virus nucleic acid ivd, kit, nucleic acid technique (nat) - the hcv vl assay, performed on genexpert? instrument systems, is designed for the rapid quantitation of hepatitis c virus (hcv) rna in human serum or plasma (edta) from hcv-infected individuals. the test utilizes automated reverse transcriptase polymerase chain reaction (rt-pcr) using fluorescence to detect the rna of interest for the quantitation of hcv. the hcv vl assay is intended for use as an aid in the management of hcv infected patients undergoing antiviral therapy. the hcv vl assay, performed on genexpert? instrument systems, is designed for the rapid quantitation of hepatitis c virus (hcv) rna in human serum or plasma (edta) from hcv-infected individuals. the test utilizes automated reverse transcriptase polymerase chain reaction (rt-pcr) using fluorescence to detect the rna of interest for the quantitation of hcv. the hcv vl assay is intended for use as an aid in the management of hcv infected patients undergoing antiviral therapy. results from the hcv vl assay may also be used to confirm hcv infection in anti-hcv positive individuals. the assay is intended to be used by laboratory professionals or specifically-trained healthcare workers.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct936 - specimen receptacle ivds - the xpert? swab specimen collection kit is designed to collect, preserve, and transport endocervical, vaginal, pharyngeal, and rectal swab specimens. this transport system is used for testing with xpert tests.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - ct791 - mycobacteria ivds - the xpert mtb/xdr assay is a nested real-time polymerase chain reaction (pcr) in vitro diagnostic test for the detection of extensively drug resistant (xdr) mycobacterium tuberculosis (mtb) complex dna in unprocessed sputum samples or concentrated sediments prepared from sputum.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - 33722 - applicator, absorbent tipped, sterile - swabs in pouch intended for clinical samples drawing.

Australia - English - Department of Health (Therapeutic Goods Administration)

cepheid holdings pty ltd - 65196 - general specimen transport medium collection kit - swabs for collection of clinical specimens for bacteriological examination.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

cepheid, u.s.a - xpert hiv-1 qual assay with genexpert dx -

Singapore - English - HSA (Health Sciences Authority)

spd scientific pte ltd - microbiology - the xpert® ct/ng assay, performed on the genexpert instrument systems, is a qualitative in vitro real-time pcr test for the automated detection and differentiation of genomic dna from chlamydia trachomatis (ct) and/or neisseria gonorrhoeae (ng) to aid in the diagnosis of chlamydial and gonorrheal urogenital disease. the assay may be used to test the following specimens from asymptomatic and symptomatic individuals: female and male urine, endocervical swab, and patient-collected vaginal swab (collected in a clinical setting). the cepheid® xpert® ct/ng vaginal/endocervical specimen collection kit is designed to collect, preserve and transport patient ct and ng dna in endocervical and vaginal specimens prior to analysis with the cepheid xpert ct/ng assay. the cepheid® xpert® urine specimen collection kit is designed to preserve and transport ct and ng dna in first-catch male and female urine specimens prior to analysis with the cepheid xpert ct/ng assay.