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Ubuvuzi bwa HitecFDAamahugurwa -FDADIbisobanuro byaMedicalDeingeso mbi

FDADIbisobanuro byaMedicalDeingeso mbi

Ibikoresho byubuvuzi bivuga ibikoresho, ibikoresho, ibikoresho, imashini, ibikoresho, imiyoboro yinjizwamo, muri reagent ya vitro, cyangwa ibindi bintu bifitanye isano byujuje ibi bikurikira, harimo ibice, ibice, cyangwa ibikoresho: ibyo byashyizwe ku rutonde mu buryo bweruye mu cyegeranyo cy’igihugu cyandikirwa mu gihugu. cyangwa Reta zunzubumwe za Amerika Pharmacopeia cyangwa imigereka kuri bibiri bimaze kuvugwa;Yagenewe gukoreshwa mugupima indwara zinyamaswa cyangwa abantu cyangwa izindi miterere yumubiri;Cyangwa ikoreshwa mugukiza, kugabanya, cyangwa kuvura indwara;Ufite umugambi wo guhindura imikorere cyangwa imiterere yinyamaswa cyangwa umubiri wumuntu, ariko udashingiye kumyitwarire yimiti yinyamaswa cyangwa umubiri wumuntu cyangwa umubiri kugirango ugere ku ntego yambere, kandi udashingiye kuri metabolism kugirango ugere ku ntego yambere.

Icyiciro cya FDA cyibikoresho byubuvuzi

Icyiciro cya I Igenzura rusange

Icyiciro cya II kugenzura rusange + kugenzura bidasanzwe

Kumenyesha mbere (PMN), 510 (K)

Icyiciro cya III Igenzura rusange + Kwemeza isoko mbere

Kwemeza mbere (PMA)

Ihame ni ugushyira ibicuruzwa ukurikije urwego rwibyago.

Muri iki gihe FDA ifite ibyiciro birenga 1700 by'ibikoresho, igabanijwemo ibice 16 byihariye byo gusaba.