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Address: 1001 Us Hwy 202 North, Raritan, New Jersey 08869, USA
www.veridex.com |
Send Inquiry |
Phone: +1-(908)-5415843
Products: Oncology & Cancer Treatments, Enumeration Circulating Cancer Cell Immunomagnetic System (FDA Code:
NQI), Blood Circulating Epithelial Cancer Cell Control Material (FDA Code:
NRS), Circulating Tumor Cell (CTC) Tests, Lymph Node Assays, DNA FISH probes, ...
Veridex, LLC focuses on vitro diagnostic oncology products. Our products feature in the earlier disease detection and enabling personalized strategies to improve patient management and outcomes. Our p
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Address: 22740 Lunn Rd., Strongsville, Ohio 44149, USA
www.spartonmedicalsystems.com |
Send Inquiry |
Phone: +1-(440)-878-4630
FDA Registration: 3003144120 Quality: ISO 13485, CE Certified
Products: Medical Devices, Anesthetic Infusion Pump (FDA Code:
FRN), Peristaltic Infusion Pump (FDA Code:
FRN), Engineering/Design Service, Implantable Aneurysm Pressure Sensor (FDA Code:
NQH), Enumeration Circulating Cancer Cell Immunomagnetic System (FDA Code:
NQI), ...
Sparton Medical Systems deals with the design, development and manufacturing of medical devices. Some of our core competencies are precision fluidic handling systems, robotic handling systems, thermal
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Address: 2400 Baglyos Circle, Bethlehem, Pennsylvania 18020, USA
Phone: +1-(610)-332-3636
Products: Hydrogel Wound and Burn Dressing (FDA Code:
MGQ), Enumeration Circulating Cancer Cell Immunomagnetic System (FDA Code:
NQI), Blood Circulating Epithelial Cancer Cell Control Material (FDA Code:
NRS), ...
Alcan Packaging-Bethlehem is engaged in the business of blood circulating epithelial cancer cell control materials, enumeration circulating cancer cell immunomagnetic systems & hydrogel wound and burn
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EMAIL INQUIRY to 3 Enumeration Circulating Cancer Cell Immunomagnetic System suppliers
FDA Code / Regulation: NQI / 866.6020 An immunomagnetic circulating cancer cell selection and enumeration system is a device that consists of biological probes, fluorochromes, and other reagents; preservation and preparation devices; and a semiautomated analytical instrument to select and count circulating cancer cells in a prepared sample of whole blood. This device is intended for adjunctive use in monitoring or predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled "Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System." See 866.1(e) for availability of this guidance document.