Clinical chemistry-specific protein IVDs
Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
Javno poročilo o oceni
(PAR)
08-11-2017
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Dostopno od:
Grifols Australia Pty Ltd
Razred:
Class 2
Izdeluje:
Progenika Biopharma SA Parque Tecnologico de Bizkaia Ibaizabl bidea Edificio 504, Derio, 48160 Spain
Terapevtsko območje:
CT974 - Clinical chemistry-specific protein IVDs
Terapevtske indikacije:
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.
Status dovoljenje:
A
Datum dovoljenje:
2014-08-06
