Bioplex 2200 MMRV Igg It on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator Set, and Biopl

Q: What is the product code of K111072?

The FDA product code is OPL – Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3510.

FDA 510(k) K111072 · Bio-Rad Laboratories

Substantially Equivalent

510(k) numberK111072

Submission

Device name: Bioplex 2200 MMRV Igg It on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator Set, and Biopl
Applicant: Bio-Rad Laboratories
Benicia, CA, US
Received: April 18, 2011
Decision date: August 23, 2011
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OPL – Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.3510
Specialty: Microbiology

The test is a multiplex immunoassay intended for the qualitative detection of specific human IgG antibodies to measles virus, mumps virus, Rubella and varicella zoster virus (VZV) in human serum and/ or plasma. The results of this assay are intended to be used as an aid in the assessment of a patient¿s serological status to measles virus, mumps virus, Rubella and VZV. The test is not intended…

Other 510(k)s with product code OPL

510(k)	Device	Applicant	Decision
K212769	DYNEX SmartPLEX MMRV IgG Assay KitOPL · Traditional	Dynex Technologies, Inc.	09/29/2023SE
K091616	Bioplex 2200 MMRV IggOPL · Traditional	Bio-Rad Laboratories	03/29/2010SE

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Questions and answers

When was Bioplex 2200 MMRV Igg It on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator Set, and Biopl cleared by the FDA?

Bioplex 2200 MMRV Igg It on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator Set, and Biopl (K111072) received a 510(k) decision of Substantially Equivalent on August 23, 2011, 127 days after the submission was received.

What is the product code of K111072?

The FDA product code is OPL – Multiplex Immunoassay For Measles Virus, Mumps Virus, Rubella And Varicella Zoster Virus, a Class II (moderate risk) device regulated under 21 CFR 866.3510.