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FDA 510(k)

BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS

K-Number: K103798 · 2011-03-18

ApplicantBecton, Dickinson & CO
Decision Date2011-03-18
Product CodeOQO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS is the device name listed in this FDA 510(k) record. The listed applicant is Becton, Dickinson & CO. It received FDA 510(k) clearance on 2011-03-18 under 510(k) number K103798. The device is classified under product code OQO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS?

BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS is a medical device that received FDA 510(k) clearance on 2011-03-18. The listed applicant is Becton, Dickinson & CO. The 510(k) number is K103798.

When did BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS receive FDA 510(k) clearance?

BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS received FDA 510(k) clearance on 2011-03-18, under 510(k) number K103798.

Who is the listed applicant for BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS?

The FDA 510(k) record lists Becton, Dickinson & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS?

The FDA product code for BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS is OQO.

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Related Devices (Code: OQO)

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.

K172509Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc.K162673Aptima Herpes Simplex Viruses 1 & 2 AssayHologic, Inc.K111951ISOAMP HSV ASSAYBiohelix CorporationK111527MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KITEragen Biosciences, Inc.K100336MULTICODE - RTX HERPES SIMPLEX VIRUS 1 AND 2 KIT, MODEL 3711Eragen Biosciences

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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