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Menarini Silicon Biosystems Inc.: FDA-registered device maker in Huntingdon Valley, PA, United States, 6 510(k) clearances

Name: Menarini Silicon Biosystems Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Menarini Silicon Biosystems Inc. is registered with the FDA (registration 3004153557) in Huntingdon Valley, PA, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 20, 2013. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004153557
Address: 3401 Masons Mill road Suite 100, Huntingdon Valley, PA, United States, 19006
Owner or operator: Menarini Silicon Biosystems Inc. (10054393)
Roles: Manufacturer, Specification developer
First device listed: March 14, 2017
Registered through: 2026
Brand names listed: CellSearch AutoPrep Samples Prep system, CellSearch CTC Control Kit, CellSearch CTC Enumeration System, CellSearch CTC Kit, CellSearch CellTracks Analyzer II, CellSearch Collection Kit, CellSearch Reagent

Devices it lists

Device	Product code	Class	Role	Source
Apparatus, Automated Blood Cell Diluting	GKH	1	Specification developer	accessdata.fda.gov
Control Material, Blood Circulating Epithelial Cancer Cell	NRS	2	Manufacturer	accessdata.fda.gov
Reagents, Specific, Analyte	MVU	1	Manufacturer	accessdata.fda.gov
System, Immunomagnetic, Circulating Cancer Cell, Enumeration	NQI	2	Manufacturer, Specification developer	accessdata.fda.gov
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 20, 2013	K130794	CELLTRACKS ANALYZER II SYSTEM	NQI	Substantially Equivalent	Veridex, LLC	accessdata.fda.gov
December 13, 2012	K122821	CELLTRACKS AUTOPREP SYSTEM	NQI	Substantially Equivalent	Veridex, LLC	accessdata.fda.gov
December 21, 2010	K103502	CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001	NQI	Substantially Equivalent	Veridex, LLC	accessdata.fda.gov
August 26, 2010	K100684	CELLTRACKS AUTOPREP SYSTEM MODEL:9541	GKH	Substantially Equivalent	Veridex, LLC	accessdata.fda.gov
June 28, 2004	K040898	CELLSEARCH EPITHELIAL CELL CONTROL KIT	NRS	Substantially Equivalent	Veridex, LLC	accessdata.fda.gov
August 8, 2003	K030596	IMMUNICON CELLSAVE PRESERVATIVE TUBE	JKA	Substantially Equivalent	Immunicon Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 20, 2022	90417	Class II	Ongoing	CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7	High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples	accessdata.fda.gov
April 4, 2018	79872	Class II	Terminated	CELLSEARCH CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH CIRCULATING Tumor Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of the epithelial origin (CD45-, EpCAM+, cytokera	Unusually high number of total images/unassigned events may require additional time and effort for the operator to review all the images and may cause a delay in reporting the results.	accessdata.fda.gov

Compare with other makers

Updated June 20, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.