Disposable Sampler Viral Transport Media

Culture Media, Non-propagating Transport

Wuxi Nest Biotechnology Co., Ltd.

The following data is part of a premarket notification filed by Wuxi Nest Biotechnology Co., Ltd. with the FDA for Disposable Sampler Viral Transport Media.

Pre-market Notification Details

Device IDK211256
510k NumberK211256
Device Name:Disposable Sampler Viral Transport Media
ClassificationCulture Media, Non-propagating Transport
Applicant Wuxi Nest Biotechnology Co., Ltd. No.530 Xida Road, New District Wuxi,  CN 214112
ContactCheng Zhiwei
CorrespondentRandy Jiang
Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin,  TX  78746
Product CodeJSM  
CFR Regulation Number866.2390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-26
Decision Date2022-05-20

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