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FDA 510(k)

BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT

K-Number: K120959 · 2012-06-22

ApplicantBio-Rad Laboratories
Decision Date2012-06-22
Product CodeMXJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2012-06-22 under 510(k) number K120959. The device is classified under product code MXJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT?

BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT is a medical device that received FDA 510(k) clearance on 2012-06-22. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K120959.

When did BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT receive FDA 510(k) clearance?

BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT received FDA 510(k) clearance on 2012-06-22, under 510(k) number K120959.

Who is the listed applicant for BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT?

The FDA 510(k) record lists Bio-Rad Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT?

The FDA product code for BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT is MXJ.

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Related Devices (Code: MXJ)

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.

K213987ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG ControlsBiokit, S.A.K220923Elecsys HSV-1 IgG (08948844160)Roche DiagnosticsK181333ADVIA Centaur Herpes-1 IgGBiokit, S.A.K162276SeraQuest Herpes Type 1 Specific IgGQuest International, Inc.K120625ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSVRoche DiagnosticsK103363ZEUS ELISA HSV GC-I IGG TEST SYSTEMZeus 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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