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)

VIDAS C DIFFICILE GDH

K-Number: K132010 · 2013-10-09

ApplicantBiomerieux S.A.
Decision Date2013-10-09
Product CodeMCB
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS C DIFFICILE GDH is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux S.A.. It received FDA 510(k) clearance on 2013-10-09 under 510(k) number K132010. The device is classified under product code MCB. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS C DIFFICILE GDH?

VIDAS C DIFFICILE GDH is a medical device that received FDA 510(k) clearance on 2013-10-09. The listed applicant is Biomerieux S.A.. The 510(k) number is K132010.

When did VIDAS C DIFFICILE GDH receive FDA 510(k) clearance?

VIDAS C DIFFICILE GDH received FDA 510(k) clearance on 2013-10-09, under 510(k) number K132010.

Who is the listed applicant for VIDAS C DIFFICILE GDH?

The FDA 510(k) record lists Biomerieux S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VIDAS C DIFFICILE GDH?

The FDA product code for VIDAS C DIFFICILE GDH is MCB.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biomerieux S.A. 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.

K250274ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)K210757ETEST Fosfomycin (FO) (0.032-512 µg/mL)K192738ETEST Delafloxacin (DFX) (0.002-32 µg/mL)K192050ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)K191953ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)K190154ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

View all 14 devices →

Related Devices (Code: MCB)

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.

K112048IMMUNOCARD C. DIFFICILE GDHMeridian Bioscience, Inc.K110620PREMIER C. DIFFICILE GDHMeridian Bioscience, Inc.K053572C. DIFF QUIK CHEKTechlab, Inc.K974881TRIAGE C. DIFFICILE, TRIAGE C. DIFFICILE PANEL, TRIAGE C. DIFFICILE TOXIN ABiosite IncorporatedK955067CLEARVIEW C. DIFF AUnipath , Ltd.K924062MERITEC C. DIFFICILE CONTROLSMeridian Diagnostics, 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.

↑