Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MagXtract Collection Tube

K-Number: K212113 · 2022-07-28

ApplicantMagbio Genomics, Inc.
Decision Date2022-07-28
Product CodeQBD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MagXtract Collection Tube is the device name listed in this FDA 510(k) record. The listed applicant is Magbio Genomics, Inc.. It received FDA 510(k) clearance on 2022-07-28 under 510(k) number K212113. 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 MagXtract Collection Tube?

MagXtract Collection Tube is a medical device that received FDA 510(k) clearance on 2022-07-28. The listed applicant is Magbio Genomics, Inc.. The 510(k) number is K212113.

When did MagXtract Collection Tube receive FDA 510(k) clearance?

MagXtract Collection Tube received FDA 510(k) clearance on 2022-07-28, under 510(k) number K212113.

Who is the listed applicant for MagXtract Collection Tube?

The FDA 510(k) record lists Magbio Genomics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagXtract Collection Tube?

The FDA product code for MagXtract Collection Tube is QBD.

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.

↑