Uma kukhulunywa ngemishini yaselabhorethri, kubalulekile ukwazi ukuthi yiziphi izinto eziwela ngaphansi kwemithetho yemishini yezokwelapha. Amathiphu e-Pipette ayingxenye ebalulekile yomsebenzi waselabhorethri, kodwa ingabe ayimishini yezokwelapha?
Ngokuya nge-US Food and Drug Administration (FDA), idivayisi yezokwelapha ichazwa njengethuluzi, idivayisi, umshini, ukufakelwa, noma enye into ehlobene esetshenziselwa ukuxilonga, ukwelapha, noma ukuvimbela isifo noma esinye isimo sezokwelapha. Nakuba amathiphu e-pipette abalulekile emsebenzini waselabhorethri, awahloselwe ukusetshenziswa kwezokwelapha ngakho-ke awafaneleki njengemishini yezokwelapha.
Noma kunjalo, lokhu akusho ukuthi amathiphu e-pipette awalawulwa ngokuphelele. I-FDA ihlukanisa amathiphu e-pipette njengemishini yaselabhorethri, elawulwa ngaphansi kwemithetho ehlukene kunemishini yezokwelapha. Ngokukhethekile, amathiphu e-pipette ahlukaniswa njenge-in vitro diagnostic device (IVD), igama elisetshenziselwa ukuchaza imishini yaselabhorethri, ama-reagents, nezinhlelo ezisetshenziselwa ukuxilonga izifo.
Njenge-IVD, amathiphu e-pipette kufanele ahlangabezane nezidingo ezithile zokulawula. I-FDA idinga ukuthi ama-IVD aphephe, asebenze kahle futhi anikeze imiphumela enembile. Ukuze kuhlangatshezwane nalezi zidingo, amathiphu e-pipette kufanele enziwe ngaphansi kwezindinganiso eziqinile zokulawula izinga futhi kufanele futhi ahlolwe ukusebenza.
Kwa-Suzhou Ace Biomedical Technology Co., Ltd., sibheka ukuthobela njengento ebaluleke kakhulu. Amathiphu ethu e-pipette akhiqizwa ngokuvumelana neziqondiso ze-FDA, ukuqinisekisa ukuthi ahlangabezana nekhwalithi ephakeme kakhulu namazinga okuphepha. Sisebenzisa kuphela izinto zokusetshenziswa ezisezingeni eliphezulu kakhulu futhi sisebenzisa amasu okukhiqiza athuthukile ukuze siqinisekise ukuthi amathiphu ethu e-pipette aletha ukunemba nokuvumelana nezimfuno zakho zelebhu.
Kafushane, nakuba amathiphu e-pipette engahlukaniswa njengemishini yezokwelapha, asangaphansi kwezidingo zokulawula njengama-IVD. Ngakho-ke, kubalulekile ukukhetha umphakeli onokwethenjelwa ofana no-Suzhou Ace Biomedical Technology Co., Ltd. ohlangabezana nazo zonke izidingo zokulawula ezidingekayo ukuze uqinisekise ukuthi umsebenzi wakho waselabhorethri unembile, uthembekile futhi uthobela zonke izindinganiso zemboni ezifanele.
Isikhathi sokuthumela: May-24-2023