Australija - engleski - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - ct887 - immunohaematology blood grouping antisera ivds - immunoglobulins capable of binding to specific red blood cell antigens and intended to be used in immunohaematological testing to provide information about red blood cell antigen phenotypes.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - ct1039 - human platelet antigen (hpa) typing ivds - intended to be used in tissue typing to provide information about the specificity of human platelet antigens (hpa). multiple human platelet antigen (hpa) typing.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - ct943 - instrument/analyser ivds - manual, semi-automated or automated equipment or apparatus that are intended to be used as an in vitro diagnostic medical device for the purposes of processing, examining and/or providing information about a clinical specimen.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - ct974 - clinical chemistry-specific protein ivds - an enzyme-linked immunosorbent assay (elisa) for the quantitative determination of anti-drug antibodies in human serum samples. the amount of anti-drug antibodies, when considered in conjunction with drug levels and clinical findings, like disease activity, can contribute valuable information to the physician to assess the efficacy of therapies with drug.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - ct860 - clinical chemistry therapeutic drug monitoring ivds - an enzyme-linked immunosorbent assay (elisa) or its assayed quality control for the quantitative determination of drug levels in human serum samples. the amount of drug, when considered in conjunction with the anti-drug antibodies and clinical findings, like disease activity, contributes valuable information to the physician to assess the efficacy of therapies with the drugs, predict infusion-related reactions and loss of clinical response by the patient.

Australija - engleski - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd -

Australija - engleski - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd -

Australija - engleski - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - ct910 - interpretive software ivds - a1at genotyping test analysis software used in a1at genotyping kit which is a qualitative, polymerase chain reaction (pcr) and hybridization-based in vitro diagnostic test to be used with the luminex 200tm instrument (with xponent? software) for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the alpha-1 antitrypsin (a1at) codifying gene serpina1. the test is intended for use with genomic dna extracted from human whole blood samples collected as dry blood spots (dbs) or in k2-edta. the a1at allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with a1at deficiency (a1atd).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - ct903 - inborn/inherited genetic disorder ivds - the progenika a1at genotyping kit (reagents and software) is a qualitative, polymerase chain reaction (pcr) and hybridization-based in vitro diagnostic test for the simultaneous detection and identification of 14 allelic variants and their associated alleles found in the alpha-1 antitrypsin (a1at) codifying gene serpina1. the test is intended for use with genomic dna extracted from human whole blood samples collected as dry blood spots (dbs) or in edta and from human saliva samples collected as buccal swabs the a1at allelic variant genotypes and associated allele results, when used in conjunction with clinical findings and other laboratory tests, are intended as an aid in the diagnosis of individuals with a1at deficiency (a1atd).

Australija - engleski - Department of Health (Therapeutic Goods Administration)

grifols australia pty ltd - ct1250 - analyser software ivds - blood stream software is a standalone software used in blood screening, as a data management software. bloodstream may be configured to connect to instrumentation in a blood screening facility including poolers, automation software (a track system), blood testing instrumentation, and a laboratory information system (lis). bloodstream also contains a user interface (ui) that allows users of bloodstream to monitor the testing progress of donations in their lab, as well as allowing limited interaction in the testing process such as modifying or cancelling orders, reviewing, and approving results. management of test orders for a donor from a laboratory information system (lis) ? management of pools and testing assigned to pools ? management of lysates and testing assigned to lysates ? handling order and result communication to/from blood testing instrumentation ? allows review, approval, and modification* of result data produced by blood testing instrumentation prior to sending it to the lis (*note: modify the existing reports, and only as it relates to: cell data source, displayed columns, comments, layout or formatting, print options, and header and footer contents of the report. it does not pertain to actually changing or modifying the results or data.) ? assignment of results from pools to the constituent donors contained within that pool ? assignment of results from lysates to the constituent donor contained within that lysate ? provides indications to the user of the health of the instrument and reagents used to produce a result ? produces informational reports on the processing and handling of donations