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FDA 510(k)

VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST

K-Number: K122514 · 2012-09-19

ApplicantNanosphere, Inc.
Decision Date2012-09-19
Product CodePAM
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST is the device name listed in this FDA 510(k) record. The listed applicant is Nanosphere, Inc.. It received FDA 510(k) clearance on 2012-09-19 under 510(k) number K122514. The device is classified under product code PAM. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST?

VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST is a medical device that received FDA 510(k) clearance on 2012-09-19. The listed applicant is Nanosphere, Inc.. The 510(k) number is K122514.

When did VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST receive FDA 510(k) clearance?

VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST received FDA 510(k) clearance on 2012-09-19, under 510(k) number K122514.

Who is the listed applicant for VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST?

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 GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST?

The FDA product code for VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST is PAM.

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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.

K123197VERIGENE C. DIFFICILE NUCLEIC ACID TEST (CDF)K120466VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)K112424VERIGENE 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: PAM)

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.

K254194QIAstat-Dx BCID GPF Plus AMR PanelQIAGEN GmbHK243490LIAISON PLEX Gram-Positive Blood Culture AssayLuminex CorporationK181663ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelGenmark Diagnostics, IncorporatedK163390iC-GPC Assay TM for use on the iC-SystemTMIcubate, Inc.K152470Great Basin Staph ID/R Blood Culture PanelGreat Basin Scientific, 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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