Icyemezo cya EU IVDR kumutwe wihuse antigen ikizamini

Amabara ya Amajwi axio atangaza gutangariza icyemezo cya EU IVDR kugirango ifatanye na rapid antigen ikizamini cya Antiden.

EU IVDR Certification for Strep A Rapid Antigen Test Kit.png

Hangzhou, Ubushinwa - Ibara ryisi yose ibisubizo bya filile, uyumunsi byatangaje ko umurongo wacyo ugabanya ubuvuzi bwa FITRO. Iyi ntambwe ishimangira ibicuruzwa byubahirizwa numutekano wa EU cyane, hamwe nubuziranenge bwuzuye, kwandura urugo rwumutwe (gaze).

Urwego rwa IVDR, rwashyizeho gushyira imbere umutekano wubwavuriro no gukorera mu mucyo, manda isuzuma rikomeye, kwemeza amavuriro, no kugenzura ubuziranenge. Icyemezo cya Coopcom bio cyerekana ko guhuza ibipimo ngenderwaho ku isi, bituma bifata vuba mu bihugu 27 by'Umuryango w'Abanyamuryango ba Eu kandi bishimangira uruhare rwayo mu kurwanya ihohoterwa ridahwitse binyuze mu kwisuzumisha binyuze mu kwisuzumisha.

Itsinda ryimikorere (gaze), impamvu nyamukuru ya pharyngitis numuriro utukura, bigira uruhare rurenga 500.000 kwisi yose. Uburyo gakondo bwa bagiteri bwa bagiteri, nubwo bwuzuye, busaba 24 - amasaha 48 yo kubisubizo. Ibara rya Coopcom bio - Ubwumvikane Bwiza mu minota 5, bigamura ingo, amashuri, n'amavuko kugirango bafate ibyemezo ku gihe. Ibyiza byingenzi birimo:

- > 95% yubuvuzi & umwihariko

- Umukoresha - Igishushanyo cya gicuti: Nta mahugurwa yihariye asabwa

- Gushyira mu bikorwa: byemejwe kubantu bakuru nabana (imyaka 3+)

Byoroheje Batatu - Kwipimisha Intambwe

Kusanya: Swab ahantu h'umuhogo wo mu muhogo.

Inzira: Kuvanga swab hamwe no gukuramo buffer hanyuma usabe cassette yikizamini.

Soma: ibisubizo bigaragara muminota 5-isobanutse neza / imirongo mibi.

Mugufasha kumenya hakiri kare, ibikoresho bifasha kugabanya gukoresha antibiyotike bitari ngombwa no gukumira ingorane zikomeye nka rusani.


Igihe cyagenwe: 2025 - 05 - 12 16 16:57:27
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