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??? ???(Zymo Research), COVID-19 ?? ??? ? ?? ??? FDA? 510(k) ?? ??

Zymo Research Corp.

2021-03-12 10:17 1,185

??? 510(k) ??? COVID-19 ???? ????

???, ?????, 2021? 3? 12? /PRNewswire/ -- ??? ???? ?? ? ??? ??(Class II)?? ???? ?? ?????(FDA)? ??? ????? ????. FDA? 510(k)??? ??? ? ??? COVID-19???? ?? ???? ????(IVD)? ??? ? ??.

The FDA has cleared Zymo Research’s DNA/RNA Shield? Collection Tube as a Class II medical device. The FDA’s 510(k) clearance allows the product to be used as an In-vitro Diagnostic (IVD) device for COVID-19 testing.

?? ?? ?? COVID-19 ?????? DNA/RNA Shield^? ???? ????? ???? SARS-CoV-2 RNA? ???? FDA??? ?? ??? ????. ????? ????? ?????? ??? ???? ??, ?? ? ??? ????. ?? ???? ???? ????? ??? ????. RNA ????? ?? ??? ??? ?? ??? ?? ?? ?? ??(RT-PCR)??? ?? ?? ???? ?????.

"DNA/RNA Shield? ??? ??? ???? ??? ??? ?? ???? ???? ??? ? ??, COVID ?? ?????? ??? ?? ? ??? ???? ??"? ??? ??? ???? ????? ?? ?? ? ??? ???. ?? "510(k)? FDA? ??????? ????? ???? ? ??? ?? ???? ?? ??? ?? ??? ?????"?? ???.

? ??? ??? ??? ??? DNA/RNA Shield^? ????? ??? ??? ????. ? ????? ??? ?? ? ???? ? ?? 28??? ???? SARS-CoV-2 RNA? ???? ????. DNA/RNA Shield^? ????? ??, ?? ??? ?? ??? ?????, ????? ?? ??? ? ? ??.

? ??? SARS-CoV-2? ??? ??? ???? ???? ?/?? ??? ?? ??? ????. DNA/RNA Shield^? ?? ??? ?? ? ??? ??? ??? ?? ?? ??? ??? ????.

??? ??? ??? ??? ????? ??? ? ?? ??????.

??? ???(Zymo Research Corp.) ??

??? ???(Zymo Research)? 1994? ?? ??? ????? ??? ???? ?? ? ?? ?? ??? ??? ? ??????. "??? ??? ??? ????? ?(The Beauty of Science is to Make Things Simple)"??? ?? ???? ? ? ??? ??????? DNA/RNA ?? ??? ????? ??? ? ??? ??? ????? ??? ????. ??? ???(Zymo Research)? ???? ?? ????? ??? ?? ??, ???? ??? ??, ?? ?? ? NGS ??? ?? ?????? ??? ????? ??? ??? ????. , , ? ?? ??? ???(Zymo Research)? ???????.

??? ???? COVID-19 ??? ??? ??? ?? ??? ??????.

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??: Zymo Research Corp.

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