OWE

Product Code: OWE

Products Classified as OWE

5043

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

Total Product Life Cycle (TPLC) Devices

5043

Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement

Pre-market Approvals for OWE

P110012

Vysis ALK Break Apart Fish Probe Kit

ABBOTT MOLECULAR, INC.

Global Unique Device Identification Database

• 00884999042773: Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
• 00884999042728: Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
• 00884999038189: Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
• 00884999025745: Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
• 00884999000735: Fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement

Maude Adverse Events

PROBECHEK ALK POSITIVE CONTROL SLIDES	ABBOTT MOLECULAR, INC.	2018-02-26
PROBECHECK ALK POSITIVE CONTROL SLIDES	ABBOTT MOLECULAR, INC.	2016-08-10
VYSIS ALK BREAK APART FISH PROBE KIT	ABBOTT MOLECULAR, INC.	2015-07-31
PROBECHECK ALK NEGATIVE CONTROL SLIDES	ABBOTT MOLECULAR, INC.	2013-09-20
PROBECHEK ALK NEGATIVE CONTROL SLIDES	ABBOTT MOLECULAR, INC.	2013-05-14
PROBECHECK ALK NEGATIVE CONTROL SLIDES	ABBOTT MOLECULAR, INC.	2012-04-18