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

in vitro technologies pty ltd - ct353 - bacterial infectious disease ivds - ivds that are intended to be used in testing to provide information about infection with or exposure to one or a number of bacterial diseases, such as clostridium difficile and mycoplasma pneumoniae, in various human swabs and samples.

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

national serology reference laboratory - ct353 - bacterial infectious disease ivds - non assay-specific infectious disease quality control material intended for use with ivds that detect bacterial dna/rna, antigens or antibodies to bacterial infectious organisms in human plasma, serum samples or other samples of human origin

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

hyp investment pty ltd - ct353 - bacterial infectious disease ivds - the products under this registration are reagent kits intended to be used on immunoassay analyzers to detect the presence and determine the concentration of various bacterial antigens in a given sample for diagnostics purpose. the products are to be used in a laboratory setting and operated by professionally trained staff. the results generated by these reagent kits are to be interpret by professionally trained physicians or general practitioners.

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

f&m family trust t/a cell biosciences - ct353 - bacterial infectious disease ivds - non assay specific bacterial qc material not intended for monitoring class 4 devices

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

hologic (australia & new zealand) pty ltd - ct353 - bacterial infectious disease ivds - the aptima? bv assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (tma) for detection and quantitation of ribosomal rna from bacteria associated with bacterial vaginosis (bv), including lactobacillus (l. gasseri, l. crispatus, and l. jensenii), gardnerella vaginalis, and atopobium vaginae. the assay reports a qualitative result for bv and does not report results for individual organisms. the assay is intended to aid in the diagnosis of bv on the automated panther? system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.

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

abacus dx pty ltd - ct353 - bacterial infectious disease ivds - qualitative tests for the detection of bacterial species in human whole blood specimens from patients with suspected bacteremia.

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

compliance management solutions - ct353 - bacterial infectious disease ivds - ivds that are intended to be used in testing to provide information about infection with or exposure to one or a number of bacterial diseases. for laboratory use only.

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

becton dickinson pty ltd - ct353 - bacterial infectious disease ivds - ivds that are intended to be used in testing to provide information about infection with or exposure to bacterial diseases. for example but not limited to rapid detection of group a streptococcus in the laboratory and/or point of care environments.

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

immuno pty ltd - ct353 - bacterial infectious disease ivds - ivds that are intended to be used in testing to provide information about infection with or exposure to one or a number of bacterial diseases.

United States - English - NLM (National Library of Medicine)

tsm ithalat ihracat sanayi ve dis ticaret limited sirketi - benzalkonium chloride 0.13%.................anitbacterial hand soap - antibacterial for handwashing to decrease bacteria on the skin - irritation or redness develops - condition persists for more than 72 hours