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FDA 510(k)

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO

K-Number: K161816 · 2017-03-28

ApplicantbioMerieux, Inc.
Decision Date2017-03-28
Product CodeMDB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO is a medical device manufactured by bioMerieux, Inc.. It received FDA 510(k) clearance on 2017-03-28 under approval number K161816. The device is classified under product code MDB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO?

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO is a medical device that received FDA 510(k) clearance on 2017-03-28. It is manufactured by bioMerieux, Inc.. The 510(k) number is K161816.

When was BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO approved by the FDA?

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO received FDA 510(k) clearance on 2017-03-28, under approval number K161816.

What company makes BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO?

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO is manufactured by bioMerieux, Inc..

What is the FDA product code for BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO?

The FDA product code for BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO is MDB.

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Related PubMed Literature

PMID: 40801347 Loop-mediated isothermal amplification (LAMP)-based microbial detection: a review of FDA-authorized tests and future perspectives. Critical reviews in clinical laboratory sciences (2026) PMID: 32459382 Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine (2020) PMID: 29111623 Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System. Final order. Federal register (2017) PMID: 27847262 The AngelMed Guardian system: Is there a role for implantable devices for early detection of coronary artery occlusion? Cardiovascular revascularization medicine : including molecular interventions (2016)

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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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