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FDA 510(k)

DENV Detect NS1 ELISA

K-Number: K181473 · 2018-08-27

ApplicantInBios International, Inc.
Decision Date2018-08-27
Product CodeQCU
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DENV Detect NS1 ELISA is a medical device manufactured by InBios International, Inc.. It received FDA 510(k) clearance on 2018-08-27 under approval number K181473. The device is classified under product code QCU. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENV Detect NS1 ELISA?

DENV Detect NS1 ELISA is a medical device that received FDA 510(k) clearance on 2018-08-27. It is manufactured by InBios International, Inc.. The 510(k) number is K181473.

When was DENV Detect NS1 ELISA approved by the FDA?

DENV Detect NS1 ELISA received FDA 510(k) clearance on 2018-08-27, under approval number K181473.

What company makes DENV Detect NS1 ELISA?

DENV Detect NS1 ELISA is manufactured by InBios International, Inc..

What is the FDA product code for DENV Detect NS1 ELISA?

The FDA product code for DENV Detect NS1 ELISA is QCU.

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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.

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