오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

hologic (australia & new zealand) pty ltd - 66632 - radio-frequency endometrial-ablation system handpiece/electrode - the system is intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia due to benign causes for whom childbearing is complete. the disposable device is a sterile device consisting of a single-patient use, conformable bipolar electrode array mounted on a frame that expands to a triangle-like shape when deployed in the uterus. the disposable device attaches to the rf controller to form the system.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

hologic (australia & new zealand) pty ltd - ct792 - mycoplasma ivds - the aptima mycoplasma genitalium assay is an in vitro nucleic acid amplification test (naat) for the qualitative detection of ribosomal rna (rrna) from m. genitalium on the fully automated panther system. it is intended for use as an aid in the diagnosis of m. genitalium urogenital infections in male and female patients.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

hologic (australia & new zealand) pty ltd - ct704 - hepatitis b virus ivds - the aptima hbv quant assay is an in vitro nucleic acid amplification test for the quantitation of hepatitis b virus (hbv) dna in human plasma and serum on the fully automated panther? system and is intended for use as an aid in the management of patients with chronic hbv infections undergoing hbv antiviral drug therapy.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

hologic (australia & new zealand) pty ltd - 48465 - hiv1 nucleic acid ivd, calibrator - to complete assay calibration a single positive calibrator is run in triplicate each time a reagent kit is loaded on the automated panther system. once established the calibration is valid for up to 24 hours. calibration kit which is used to establish known points of reference for the aptima hiv-1 quant dx assay (nat) for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (hiv1)in a clinical specimen on the fully automated panther system.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

hologic (australia & new zealand) pty ltd - 48466 - hiv1 nucleic acid ivd, control - one replicate of the aptima hiv-1 quant dx negative control, of the low positive control and of the high positive control must be tested each time a reagent kit is loaded on the panther system to enable generation of valid results. once established the controls are valid for up to 24hrs. control kit which is used to verify the performance of the aptima hiv-1 quant dx assay (nat)for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (hiv1)in a clinical specimen on the fully automated panther system.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

hologic (australia & new zealand) pty ltd - 30768 - hiv1 nucleic acid ivd, kit, nucleic acid technique (nat) - a collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of hiv-1 nucleic acid in a clinical specimen, using a nucleic acid technique (nat). the aptima hiv-1 quant dx assay is an in vitro nucleic acid amplification test for the detection and quantification of human immunodeficiency virus type 1 (hiv-1) rna groups m, n, o and is intended for use as an aid in the diagnosis of hiv-1 infection, as confirmation of hiv-1 infection, and as an aid in clinical management of patients infected with hiv-1.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

hologic (australia & new zealand) pty ltd - ct943 - instrument/analyser ivds - instruments to be used as ivds for the purposes of processing, examining and providing information about clinical specimens

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

hologic (australia & new zealand) pty ltd - ct936 - specimen receptacle ivds - kits containing items for the collection and vessels for the containment, preservation and/or transport of all clinical specimens for analysis or investigation.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

hologic (australia & new zealand) pty ltd - ct945 - general laboratoryware ivds - general reagents, laboratory products, consumables, biological stains, antimicrobial identification tests and antimicrobial susceptibility tests.

오스트레일리아 - 영어 - Department of Health (Therapeutic Goods Administration)

hologic (australia & new zealand) pty ltd - ct947 - human papilloma virus ivds - the aptima hpv assay is a target amplification nucleic acid probe test for the in vitro qualitative detection of e6/e7 viral messenger rna (mrna) from 14 high-risk hpv types of human papillomavirus (hpv) (16/18/31/33/35/39/45/51/52/56/58/59/66/68). the aptima hpv assay does not discriminate between the 14 high-risk types. the aptima hpv 16 18/45 genotype assay is an in vitro nucleic acid amplification test for the qualitative detection of e6/e7 viral messenger rna (mrna) from human papillomavirus (hpv) high-risk types 16, 18, and 45 in samples from women with positive aptima hpv assay results.