FDA Device Entity Profile: Diagnostica Stago, Inc.

Known Identifiers & Locations

FEI Numbers 2245451

Owner Operator Numbers 9003476

Locations Covered PARSIPPANY, NJ, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2245451	DIAGNOSTICA STAGO, INC.	PARSIPPANY, NJ, US	Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0039-2008	STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic. Reason: Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.	2007-07-30	Terminated	View Details

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