FDA Device Entity Profile: bioMerieux, Inc.

Known Identifiers & Locations

FEI Numbers 1950204, 3002769706

Owner Operator Numbers N/A

Locations Covered N/A

Registered Establishments (0)

No device registration and listing records found for this entity.

510(k) Premarket Notifications (2)

Submission #	Device Name	Decision Date	Decision Description	Action
K112000	VITEK 2 STREPTOCOCCUS PENICILLIN	2011-10-26	Substantially Equivalent	View Details
K232967	VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)	2024-06-12	Substantially Equivalent	View Details

FDA Recall History (2)

Recall #	Product Description	Initiation Date	Status	Action
Z-0023-2013	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples. Reason: The instrument may not dispense the specimen onto the pre-poured media resulting in a false negative result.	2012-08-28	Terminated	View Details
Z-0032-06	VeriCal Calibrator Set Reason: The product is being recalled due to mis-assignment of ISI values associated with VeriCal use.	2005-08-19	Terminated	View Details

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