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FDA 510(k)

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)

K-Number: K123197 · 2012-12-05

ApplicantNanosphere, Inc.
Decision Date2012-12-05
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) is the device name listed in this FDA 510(k) record. The listed applicant is Nanosphere, Inc.. It received FDA 510(k) clearance on 2012-12-05 under 510(k) number K123197. 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 VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)?

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) is a medical device that received FDA 510(k) clearance on 2012-12-05. The listed applicant is Nanosphere, Inc.. The 510(k) number is K123197.

When did VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) receive FDA 510(k) clearance?

VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) received FDA 510(k) clearance on 2012-12-05, under 510(k) number K123197.

Who is the listed applicant for VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)?

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

What is the FDA product code for VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)?

The FDA product code for VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF) is OZN.

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Other records listing Nanosphere, 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.

K120466VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)K122514VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TESTK112424VERIGENE STAPHYLOCOCCUS BLOOD CULTURE NUCLEIC ACID TEST (BC-S)K103209VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST +(RVNAT+)K093337VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEMK092957VERIGENE SYSTEM, VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST

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Related Devices (Code: OZN)

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.

K260045cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190)Roche Molecular Systems, Inc.K243730Xpert C. difficile/EpiCepheid®K232092Great Basin Toxigenic C. difficile Direct Test (CDF2)Vela Operations USAK212427cobas 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.K172569GenePOC CDiffGenepoc, 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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