Uvavanyo lweMacro kunye noVavanyo oluNcinci ezintlanu iimveliso ezivunywe yi-US FDA

Ngomhla we-30 kaJanuwari kunye nomsitho woNyaka oMtsha waseTshayina, iimveliso ezintlanu eziphuhliswe yiMacro & Micro-Test, Easy Amp Real-time Fluorescence Isothermal Detection System, Micro-Test Automatic Nucleic Acid Extractor, Macro & Micro-Test Viral DNA/RNA Kit , I-Macro kunye ne-Micro-Test ye-Sample Release Reagent, kunye ne-Macro kunye ne-Micro-Test yeSampulu yokuqokelela, i-Mailing & Shipping Kit iye yacinywa kwaye yavunywa yi-US FDA ngokulandelanayo.

Uvavanyo olukhulu noluncinci
Uvavanyo olukhulu noluncinci1
Macro&Micro-Test2

Ukutya, ichiza, izithambiso kunye nezixhobo zonyango ezivunywe yi-US Food and Drug Administration (FDA), ezivunywe ngamazwe ngamazwe njengegunya lokuvunywa kwezixhobo zonyango, zimveliso eziphandwayo kwaye zigunyaziswe yimigangatho egunyazisiweyo yehlabathi.Ezi zintlanu zingasentla iimveliso ezigunyazisiweyo ze-FDA ezivela kwiMacro & Micro-Test zigubungela yonke inkqubo yovavanyo lwenucleic.

 

1. Isampuli

Uvavanyo olukhulu noluncinci3

Ubukhulu obubini obahlukeneyo, i-swab eqhekekileyo eyophuka jikelele, ukungasebenzi kwentsholongwane okusebenzayo, okusebenzayo ekubhaqweni okuxutyiweyo.

2. Ukutsalwa kwe-Acid yeNucleic
● Inkqubo A

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Macro & Micro-Test Viral DNA/RNA Kit
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I-Automatic Nucleic Acid Extractor

I-Automatic Nucleic Acid Extractor iqhutywe ngezantsi enye kuphela, ikhulula izandla zabasebenzi bezonyango.NgeMacro & Micro-Test Viral DNA/RNA Kit, inkqubo yokutsalwa kwe-nucleic acid ingagqitywakwimizuzu eli-10, ukukhawulezisa kakhulu umsebenzi kunye nokunciphisa imithwalo kwiilabhoratri.

● Inkqubo B

Uvavanyo olukhulu noluncinci5

IMakhro kunye neMicro-Test yokuKhupha iSampuli yeReagent

Ukusasazeka kwe-SARS-CoV-2 Virus kuzise uxinzelelo olukhulu kubasebenzi bezonyango nakwiilabhoratri, abanobunzima bokwenza uvavanyo lomthamo ophezulu othintelwe yindawo, ixesha, izixhobo kunye nabasebenzi.Ukuthathela ingqalelo oku, iMacro kunye neMicro-Test iphuhlise isisombululo sokukhulisa inyathelo elinye:isampula yotsalo kwimizuzu emi-5 ngaphandle koncedo lwesixhobo.

3. I-Isothermal Amplification

Uvavanyo olukhulu noluncinci7

Xa kuthelekiswa novavanyo lwePCR lwemveli, iEasy Amp Real-time Fluorescence Isothermal Detection System, eneziphumo ezincumisayo.kwimizuzu emi-5, iye yanciphisa yonke inkqubo yokufumanisa nge-2/3.Yi-4x4 iimodyuli eziyilwe ngokuzimeleyo ziqinisekisa uvavanyo olufunekayo kunye nesiphumo esichanekileyo kumanyathelo amathathu.

Ngamana unyaka omtsha kunye nomnyaka we-tiger ugcwele ulonwabo.


Ixesha lokuposa: Aug-01-2022