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Hitec MedicalFDAtababarka -FDA'sDqeexiddaMedicalDexumaan

FDADqeexiddaMedicalDexumaan

Aaladaha caafimaadku waxay tixraacaan qalabka, qalabka, qalabka, mishiinada, qalabka, tuubooyinka galinta, reagents in vitro, ama alaabta kale ee la xidhiidha ee buuxisa shuruudaha soo socda, oo ay ku jiraan qaybaha, qaybaha, ama qalabyada: kuwa si cad ugu qoran liiska rasmiga ah ee qaranka ee ururinta daawoyinka ama Pharmacopeia-ka Maraykanka ama ku-xirnaanta labada aan soo sheegnay;Loogu talagalay in loo isticmaalo ogaanshaha cudurrada xayawaanka ama aadanaha ama xaaladaha kale ee jirka;Ama loo isticmaalo daaweynta, yaraynta, ama daaweynta cudurrada;La rabo in uu saameeyo shaqada ama qaab-dhismeedka xayawaanka ama jidhka bini'aadamka, laakiin iyada oo aan lagu tiirsanayn falcelinta kiimikada ee xayawaanka ama jidhka bini'aadamka si loo gaaro ujeeddadeeda aasaasiga ah, iyo iyada oo aan lagu tiirsanayn dheef-shiid kiimikaad si loo gaaro ujeeddadeeda koowaad.

Kala soocidda FDA ee qalabka caafimaadka

Xakamaynta guud ee fasalka I

Xakamaynta guud ee fasalka II+ xakamaynta gaarka ah

Ogeysiinta Premarket-ka (PMN), 510 (K)

Heerka III Xakamaynta Guud+Oggolaanshaha Kahor Suuqa

Oggolaanshaha Premarket-ka (PMA)

Mabda'a ayaa ah in la kala saaro badeecadaha iyadoo lagu saleynayo heerka khatarta.

FDA waxay hadda leedahay in ka badan 1700 oo qaybood oo qalab ah, oo loo qaybiyay 16 goobood oo khaas ah.