FDA Device Entity Profile: LOUISVILLE APL DIAGNOSTICS, INC.

Known Identifiers & Locations

FEI Numbers 1000305932

Owner Operator Numbers 9008974

Locations Covered Texas City, TX, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
1529254	LOUISVILLE APL DIAGNOSTICS, INC.	Texas City, TX, 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-0034-2008	APhL HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; in vitro diagnostic. Distributed by Louisville APL Diagnostics, Inc., Doraville, GA 30360 (address now in Seabrook, TX 77856). Reason: Product mislabeled; outer container labeled with incorrect lot number.	2006-07-18	Terminated	View Details

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