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FDA 510(k)

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit

K-Number: K171441 · 2017-07-21

ApplicantLuminex Corporation
Decision Date2017-07-21
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is a medical device manufactured by Luminex Corporation. It received FDA 510(k) clearance on 2017-07-21 under approval number K171441. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is a medical device that received FDA 510(k) clearance on 2017-07-21. It is manufactured by Luminex Corporation. The 510(k) number is K171441.

When was ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit approved by the FDA?

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit received FDA 510(k) clearance on 2017-07-21, under approval number K171441.

What company makes ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is manufactured by Luminex Corporation.

What is the FDA product code for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit?

The FDA product code for ARIES C. difficile Assay Complete Kit, ARIES C. difficile Assay Protocol File Kit, ARIES C. difficile Assay Kit (24 cassettes), ARIES Stool Resuspension Kit is OZN.

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Related PubMed Literature

PMID: 42043121 Validation of the Epi2SensA Method Using the EpiDerm™ Model for Skin Sensitization Testing Under OECD TG442D. Toxics (2026)

Other Devices by Luminex Corporation

K162772ARIES GBS Assay K161220ARIES® Flu A/B & RSV Assay K161495ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD) K160517ARIES System K172402ARIES Group A Strep Assay, ARIES Group A Strep Assay Protocol File Kit K163626ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit

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Related Devices (Code: OZN)

K172569GenePOC CDiffGenepoc, Inc. K171770cobas Cdiff Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. K170491Solana C. difficile AssayQuidel Corporation K163085Simplexa C. difficile Direct; Simplexa C. difficile Positive Control PackFocus Diagnostics, Inc.:Dba Diasorin Molecular, LLC K212427cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc. K210385cobas Cdiff nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.

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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