Siemens Healthineers gba aṣẹ lilo pajawiri FDA fun idanwo antibody SARS-CoV-2

Niu Yoki-Ni ọsẹ to kọja, Ile-iṣẹ Ounje ati Oògùn funni ni aṣẹ pajawiri Siemens Healthineers fun lilo Advia Centaur SARS-CoV-2 IgG tabi idanwo sCOVG.
Chemiluminescence immunoassay jẹ apẹrẹ fun wiwa agbara ati ologbele-pipo ti immunoglobulin G tabi IgG lodi si SARS-CoV-2 ni omi ara ati pilasima.Idanwo naa wa ni ṣiṣe lori Siemens' Advia Centaur XP, Advia Centaur XPT ati Advia Centaur CP immunoassay awọn ọna ṣiṣe.
Gẹgẹbi FDA, idanwo yii le ṣee lo nipasẹ eyikeyi yàrá-ifọwọsi ti CLIA lati ṣe awọn idanwo iwọntunwọnsi tabi ti o ni idiwọn giga.
Ni Oṣu Kẹta ti ọdun yii, SARS-CoV-2 IgG immunoassay ṣiṣe nipasẹ Siemens AG, olú ni Erlangen, Jẹmánì, lori atupale Atellica IM rẹ, gba EUA lati FDA.
Asiri Afihan.Ofin ati ipo.Aṣẹ-lori-ara © 2021 GenomeWeb, ẹka iṣowo ti Crain Communications.gbogbo awọn ẹtọ wa ni ipamọ.


Akoko ifiweranṣẹ: Jun-28-2021