Devices

CELLSEARCH Circulating Tunor Cell Kit (Epithelial)

Model / Serial
UDI (01)10888385000012(17)180810(10)S038 (01)10888385000012(17)180810(10) (01)10888385000012(17)180810(10)S038S (01)10888385000012(17)180810(10)S038T (01)10888385000012(17)180810(10)S038U (01)10888385000012(17)180810(10)S038 V Serial, Batch, Lot # 2038 S038R S038S S038T S038U S038V S038W (0 distributed to the field)
Product Classification
Hematology and Pathology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - USA (nationwide) and to the countries of : Canada and Italy
Product Description
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+, cytokeratins 8, 18+, and/or 19+) in whole blood.
Manufacturer
Menarini Silicon Biosystems
1 Event
- Recall of CELLSEARCH Circulating Tunor Cell Kit (Epithelial)

Manufacturer

Menarini Silicon Biosystems

Manufacturer Address
Menarini Silicon Biosystems, 3401 Masons Mill Rd Ste 100, Huntingdon Valley PA 19006-3574
Manufacturer Parent Company (2017)
Pharmafin Spa
Source
USFDA

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