Isatifikethi se-EU

I-Colorcom I-Biostics ye-Biostics ye-Biostics ibhengeza isiqinisekiso se-EU

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

I-Hangzhou, China - I-Colorbar Bib, inkokeli yehlabathi, namhlanje ivakalise ukuba i-Pit Ract Pight Infort's I-United States ye-I-European ifumene ngempumelelo i-Europen Unististististik yonyango lwe-vitro yonyango (ivdr, eUnu ngo-2017/746). Eli nqaku lingaphantsi kolunye ukhuseleko lwemveliso kunye nokhuseleko lwe-EU, kunye nemigangatho esemgangathweni, ibeka njengesisombululo esithembileyo kwi-StoptococCCUSCUS (yegesi) yeqela.

Inkqubo-sikhokelo ye-IVDR, eyenzelwe ukubeka phambili ukhuseleko lweklinikhi kunye nokusebenza elubala, igunyazisa uvavanyo lwentsebenzo, ukuqinisekiswa kweklinikhi, kunye nokuphicothwa komgangatho. Isatifikethi se-falcococ se-bimar sibonisa ulungelelwaniso kunye ne-benchmarks yehlabathi, ukuvumela ukuthunyelwa okukhawulezayo kumazwe angama-27 e-EU kunye nokunyanzelisa indima yayo ekulweni ukuchasana nokunganyangeki.

Iqela i-stretococcus (igesi), unobangela ophambili we-payngitis kunye nefiva ebomvu, inegalelo ekufeni okungapheliyo kwi-500,000 yokufa jikelele. Iindlela ze-Bactery zeBactery, nangona zichanekile, zifuna i-24 - iiyure ezingama-48 zeziphumo. I-Colorcom Bio's Kiba ye-Bio ye-Bio ye-Bio ye-Bio ye-Bio ye-Bib - Ukuchaneka okuthelekiswayo ngaphakathi kwemizuzu emi-5, ukuxhobisa amakhaya, izikolo, kunye neekliniki zokwenza unyango. Izibonelelo eziphambili zibandakanya:

- > Iipesenti ezingama-95 zekliniki yeklinikhi kunye nezophando

- Umsebenzisi - Uyilo olunobuhlobo: Akukho uqeqesho olukhethekileyo olufunekayo

- Isicelo sesibini: Iqinisekisiwe kubo bobabini abantu abadala kunye nabantwana (iminyaka eli-3 +)

Ilula yesithathu - Uvavanyo lwenyathelo

Qokelela: jika indawo yendawo yokugcina amanzi.

Inkqubo: Hlanganisa i-swab kunye ne-buffer yokukhupha kwaye isebenze kwikhasethi yovavanyo.

Funda: Iziphumo zibonakale kwimizuzu emi-5 ecacileyo / engalunganga.

Ngokwenza ukuba kuqatshelwe kwangoko, ikhithi iyanceda ukunciphisa ukusetyenziswa okungafunekiyo kwentsholongwane kwaye kuthintele iingxaki ezinzima njengomkhuhlane we-rump.


Ixesha LEXESHA: 2025 - 05 - 12 167:27
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