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FDA 510(k)

VIDAS ROTAVIRUS (RTV) ASSAY

K-Number: K972895 · 1997-10-03

ApplicantBiomerieux Vitek, Inc.
Decision Date1997-10-03
Product CodeLIQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VIDAS ROTAVIRUS (RTV) ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1997-10-03 under 510(k) number K972895. The device is classified under product code LIQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIDAS ROTAVIRUS (RTV) ASSAY?

VIDAS ROTAVIRUS (RTV) ASSAY is a medical device that received FDA 510(k) clearance on 1997-10-03. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K972895.

When did VIDAS ROTAVIRUS (RTV) ASSAY receive FDA 510(k) clearance?

VIDAS ROTAVIRUS (RTV) ASSAY received FDA 510(k) clearance on 1997-10-03, under 510(k) number K972895.

Who is the listed applicant for VIDAS ROTAVIRUS (RTV) ASSAY?

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

What is the FDA product code for VIDAS ROTAVIRUS (RTV) ASSAY?

The FDA product code for VIDAS ROTAVIRUS (RTV) ASSAY is LIQ.

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Other records listing Biomerieux Vitek, Inc. 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.

K973819VIDAS D-DIMER (DD) ASSAYK965092VIDAS ROTAVIRUS ASSAYK964887VIDAS C. DIFFICILE TOXIN A II ASSAYK955627VIDAS CHLAMYDIA BLOCKING ASSAYK962609GRAM NEGATIVE IDENTIFICATION PLUS CARDK962549VIDAS CREATINE KINASE MB ASSAY 30-421

View all 49 devices →

Related Devices (Code: LIQ)

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.

K990842SAS ROTA TESTSa Scientific, Inc.K971585IMMUNOCARD STAT! ROTAVIRUSMeridian Diagnostics, Inc.K964424ROTAVIRUS EIATrinity Biotech, Inc.K965092VIDAS ROTAVIRUS ASSAYBiomerieux Vitek, Inc.K951208ROTA-DAN RAPID ROTAVIRUS EIA KITEldan Technologies, Ltd.K942286DIARLEX ROTA-ADENOOrion Diagnostica, 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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