FDA 510(k)

DNA/RNA Shield Collection Tube

K-Number: K202641 · 2020-12-14

Decision Date2020-12-14

Product CodeQBD

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

DNA/RNA Shield Collection Tube is a medical device manufactured by Zymo Research. It received FDA 510(k) clearance on 2020-12-14 under approval number K202641. The device is classified under product code QBD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DNA/RNA Shield Collection Tube?

DNA/RNA Shield Collection Tube is a medical device that received FDA 510(k) clearance on 2020-12-14. It is manufactured by Zymo Research. The 510(k) number is K202641.

When was DNA/RNA Shield Collection Tube approved by the FDA?

DNA/RNA Shield Collection Tube received FDA 510(k) clearance on 2020-12-14, under approval number K202641.

What company makes DNA/RNA Shield Collection Tube?

DNA/RNA Shield Collection Tube is manufactured by Zymo Research.

What is the FDA product code for DNA/RNA Shield Collection Tube?

The FDA product code for DNA/RNA Shield Collection Tube is QBD.

Other Devices by Zymo Research

K231013DNA/RNA Shield SafeCollect Saliva Collection kit

Related Devices (Code: QBD)

DEN170029PrimeStore MTMLonghorn Vaccines and Diagnostics, LLC K201849eNAT molecular collection and preservation mediumCopan Italia Spa K210440Disposable Sampler Inactivated Transport Media, Nest ITMWuxi Nest Biotechnology Co., Ltd. K211675Dasky Disposable Sampling Tube (Model name: VSM02)Ningbo Dasky Life Science Co., Ltd. K212113MagXtract Collection TubeMagbio Genomics, Inc. K231013DNA/RNA Shield SafeCollect Saliva Collection kitZymo Research

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.