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FDA 510(k)

eNAT molecular collection and preservation medium

K-Number: K201849 · 2020-09-17

ApplicantCopan Italia Spa
Decision Date2020-09-17
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

eNAT molecular collection and preservation medium is the device name listed in this FDA 510(k) record. The listed applicant is Copan Italia Spa. It received FDA 510(k) clearance on 2020-09-17 under 510(k) number K201849. 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 eNAT molecular collection and preservation medium?

eNAT molecular collection and preservation medium is a medical device that received FDA 510(k) clearance on 2020-09-17. The listed applicant is Copan Italia Spa. The 510(k) number is K201849.

When did eNAT molecular collection and preservation medium receive FDA 510(k) clearance?

eNAT molecular collection and preservation medium received FDA 510(k) clearance on 2020-09-17, under 510(k) number K201849.

Who is the listed applicant for eNAT molecular collection and preservation medium?

The FDA 510(k) record lists Copan Italia Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for eNAT molecular collection and preservation medium?

The FDA product code for eNAT molecular collection and preservation medium is QBD.

Other records listing Copan Italia Spa as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232565UriSponge™K232357Copan Universal Transport Medium (UTM-RT) SystemK220052Copan FecalSwab Collection, Transport and Preservation SystemK180052UriSwab-Urine Collection, Transport and Preservation System

Related Devices (Code: QBD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K242820Puritan PurSafe Plus Collection and Transport SystemPuritan Medical Products, LLCK240797PPH Saliva Collection KitPermantis Public HealthK222771Sample Preservative FluidHangzhou Bioer Technology Co., Ltd.K233324Molecular Transport Media - MTMAlb LuzK221547InActiv BlueFertipro NVK212878Sample preservation solutionZhejiang Gene Science Co., Ltd.

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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